Bigliani/Flatow® 4300-52-18
by Zimmer, Inc.
Listed
Valid until
Not applicable
FDA recalls
None ongoingDocuments
None
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00889024264120 | Date24 Sep 2015 | StatusListed |
Recalls
-
- Terminated Z-0298-2020
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
-
- Terminated Z-1895-2012
Bigliani/Flatow The Complete Shoulder Solution Trabecular Metal Glenoid Instrument Drill with Stop, 6 mm. Catalog number 47-4301-031-00 was actually packaged and labeled as catalog number 47-4307-031-00, lot 62071190.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade Name
- Bigliani/Flatow®
- Generic Name
- Stem-fixed metallic humeral head prosthesis
- Model / Ref / Catalog
- 4300-52-18, 00-4300-052-18
- Primary DI / UDI-DI
- 00889024264120
- FDA Product Code
- KWT, KWS, HSD
- GMDN Term
- Stem-fixed metallic humeral head prosthesis
- Device Class
- Class II
- Regulation Number
- 888.3650, 888.3660, 888.3690
- GUDID distribution status
- In Commercial Distribution
Other devices from Zimmer, Inc.
Properties
Other properties (8)
- Contains Latex: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Manufacturing Date: No