Instrument I-H2135BT07
Instrument I-H2135BT07 is a Class II device made by Howmedica Osteonics Corp., cleared under FDA 510(k) K182468 on 19 Mar 2019 and listed in FDA GUDID since 23 Apr 2019 (UDI-DI 07613327418460), 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 | Number07613327418460 | Date23 Apr 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK182468 | Date19 Mar 2019 | StatusActive |
Official records
- AccessGUDID record 07613327418460
- FDA 510(k) database K182468
Across registries
- FDA 510(k) K182468 decided 19 Mar 2019 Active
- FDA GUDID UDI-DI 07613327418460 listed 23 Apr 2019 Listed
Timeline
- Cleared FDA 510(k) K182468
- Listed FDA GUDID 07613327418460
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Instrument
- Generic name
- Orthopaedic broach
- Model / Ref / Catalog
- I-H2135BT07
- Primary DI / UDI-DI
- 07613327418460
- 510(k) Number
- FDA product code
- KWY
- GMDN term
- Orthopaedic broach
- Device class
- Class II
- Regulation number
- 888.3390
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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