Cement Plug D111-16-0250
by Signature Orthopaedics Pty Ltd
Cement Plug D111-16-0250 is a Class II device made by Signature Orthopaedics Pty Ltd, cleared under FDA 510(k) K133370 on 22 Jul 2014 and listed in FDA GUDID since 20 Sep 2022 (UDI-DI 09348215053758), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number09348215053758 | Date20 Sep 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK133370 | Date22 Jul 2014 | StatusActive |
Official records
- AccessGUDID record 09348215053758
- FDA 510(k) database K133370
Across registries
- FDA 510(k) K133370 decided 22 Jul 2014 Active
- FDA GUDID UDI-DI 09348215053758 listed 20 Sep 2022 Listed
Timeline
- Cleared FDA 510(k) K133370
- Listed FDA GUDID 09348215053758
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Cement Plug
- Generic name
- Polymer orthopaedic cement restrictor, non-bioabsorbable
- Model / reference
- D111-16-0250
- Primary DI / UDI-DI
- 09348215053758
- 510(k) Number
- FDA product code
- JDI
- GMDN term
- Polymer orthopaedic cement restrictor, non-bioabsorbable
- Device class
- Class II
- Regulation number
- 888.3350
- GUDID distribution status
- In Commercial Distribution
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