Signature Orthopedics Pty Limited
⚠️ Moderate Risk
FEI: 3008262872 • Lane Cove West, New South Wales • AUSTRALIA
FEI Number
3008262872
Location
Lane Cove West, New South Wales
Country
AUSTRALIAAddress
Lane Cove W, 7 Sirius Rd, Lane Cove West, New South Wales, Australia
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/10/2020 | 87MEHPROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALCIUM-PHOSPHATE | Division of West Coast Imports (DWCI) | |
| 8/20/2018 | 87LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 8/20/2018 | 87LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 8/20/2018 | 87LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 8/20/2018 | 87LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 8/20/2018 | 87LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 6/8/2018 | 87LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 4/23/2018 | 87LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 11/8/2017 | 87LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 11/8/2017 | 87LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 11/8/2017 | 87LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 11/8/2017 | 87LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 11/8/2017 | 87LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 11/8/2017 | 87LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 11/8/2017 | 87LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 11/8/2017 | 87LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 11/8/2017 | 87LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 6/27/2017 | 87OVDINTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR | Division of Southeast Imports (DSEI) | |
| 2/21/2014 | 87MEHPROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALCIUM-PHOSPHATE | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Signature Orthopedics Pty Limited's FDA import refusal history?
Signature Orthopedics Pty Limited (FEI: 3008262872) has 19 FDA import refusal record(s) in our database, spanning from 2/21/2014 to 3/10/2020.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Signature Orthopedics Pty Limited's FEI number is 3008262872.
What types of violations has Signature Orthopedics Pty Limited received?
Signature Orthopedics Pty Limited has been cited for 4 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Signature Orthopedics Pty Limited come from?
All FDA import refusal data for Signature Orthopedics Pty Limited is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.