Comprehensive® 110031413
by Zimmer, Inc.
Comprehensive® 110031413 is a Class II device made by Zimmer, Inc., cleared under FDA 510(k) K181611 on 24 Sep 2018 and listed in FDA GUDID since 22 Feb 2019 (UDI-DI 00887868231452), 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 | Number00887868231452 | Date22 Feb 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK181611 | Date24 Sep 2018 | StatusActive |
Official records
- AccessGUDID record 00887868231452
- FDA 510(k) database K181611
Across registries
- FDA 510(k) K181611 decided 24 Sep 2018 Active
- FDA GUDID UDI-DI 00887868231452 listed 22 Feb 2019 Listed
Timeline
- Cleared FDA 510(k) K181611
- Listed FDA GUDID 00887868231452
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Comprehensive®
- Generic name
- Reverse shoulder prosthesis body
- Model / Ref / Catalog
- 110031413
- Primary DI / UDI-DI
- 00887868231452
- 510(k) Number
- FDA product code
- PHX, KWS, KWT, PAO
- GMDN term
- Reverse shoulder prosthesis body
- Device class
- Class II
- Regulation number
- 888.3660, 888.3650
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
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