Ensemble CMC Bump Rasp
Ensemble CMC Bump Rasp (103-RSP-003) is a Class II device made by Ensemble Orthopedics, LLC, cleared under FDA 510(k) K201072 on 2 Dec 2020 and listed in FDA GUDID since 1 Aug 2023 (UDI-DI 00810063560201), active as of 22 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 | Number00810063560201 | Date1 Aug 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK201072 | Date2 Dec 2020 | StatusActive |
Official records
- AccessGUDID record 00810063560201
- FDA 510(k) database K201072
Across registries
- FDA 510(k) K201072 decided 2 Dec 2020 Active
- FDA GUDID UDI-DI 00810063560201 listed 1 Aug 2023 Listed
Timeline
- Cleared FDA 510(k) K201072
- Listed FDA GUDID 00810063560201
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Ensemble CMC
- Generic name
- Metacarpal prosthesis
- Model / Ref / Catalog
- Ensemble CMC Bump Rasp, 103-RSP-003
- Primary DI / UDI-DI
- 00810063560201
- 510(k) Number
- FDA product code
- KYI
- GMDN term
- Metacarpal prosthesis
- Device class
- Class II
- Regulation number
- 888.3770
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices
Other devices filed under FDA product code KYI (Prosthesis, Wrist, Carpal Trapezium).
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