Everglade Broach 111-45-2004
by Signature Orthopaedics Pty Ltd
Everglade Broach 111-45-2004 is a Class I device made by Signature Orthopaedics Pty Ltd, cleared under FDA 510(k) K211505 on 24 Sep 2021 and listed in FDA GUDID since 19 Aug 2022 (UDI-DI 09348215105143), 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 | Number09348215105143 | Date19 Aug 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK211505 | Date24 Sep 2021 | StatusActive |
Official records
- AccessGUDID record 09348215105143
- FDA 510(k) database K211505
Across registries
- FDA 510(k) K211505 decided 24 Sep 2021 Active
- FDA GUDID UDI-DI 09348215105143 listed 19 Aug 2022 Listed
Timeline
- Cleared FDA 510(k) K211505
- Listed FDA GUDID 09348215105143
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Everglade Broach
- Generic name
- Orthopaedic broach
- Model / reference
- 111-45-2004
- Primary DI / UDI-DI
- 09348215105143
- 510(k) Number
- FDA product code
- LXH
- GMDN term
- Orthopaedic broach
- Device class
- Class I
- Regulation number
- 888.4540
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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