Uncaptured Mini Baseplate Sizer with Captured Screw SSI005495
Listed
Valid until
Not applicable
FDA recalls
None ongoingDocuments
None
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00889024583139 | Date6 Feb 2020 | StatusListed |
Recalls
-
- Terminated Z-0093-2021
Product potentially being packaged without a taper adapter or baseplate. The package should contain one (1) baseplate and one (1) taper adapter, product may be packaged with two (2) baseplates and no (0) adapters or with no (0) baseplates and two (2) adapters
-
- Terminated Z-1615-2020
Package is intended to contain one (1) baseplate and one (1) taper adapter; however, devices may be packaged with two (2) baseplates and no (0) adapters.
-
- Terminated Z-0972-2019
The product was potentially being packaged without a taper adapter.
-
- Terminated Z-1208-2015
The taper adaptor is missing from the packaging, which may result in a delay in surgery greater than 30 minutes.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade Name
- Uncaptured Mini Baseplate Sizer with Captured Screw
- Generic Name
- Orthopaedic implant aiming/guiding block, reusable
- Model / Ref / Catalog
- SSI005495
- Primary DI / UDI-DI
- 00889024583139
- 510(k) Number
- FDA Product Code
- PHX, KWS
- GMDN Term
- Orthopaedic implant aiming/guiding block, reusable
- Device Class
- Class II
- Regulation Number
- 888.3660
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Other devices from Biomet Orthopedics, Inc.
Properties
Other properties (12)
- Sterile: No
- Single Use: No
- Implantable: No
- Contains Latex: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Expiration Date: No
- Manufacturing Date: No