Na 487.976
by Synthes GUDID
Listed
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10887587055909 | Date14 Sep 2015 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Recalls
-
- Terminated Z-1745-2013
Synthes is initiating a voluntary Medical Device removal for specified part numbers and lot numbers of the Mutis Vector Distractor Pin Holding clamp, limited bone stock. The firm received complaints that the clamp and nut construct would not engage the distractor arm threads and subsequently bind. It is not likely that a serious adverse event will result due to a nonconforming clamp, however there
-
- Terminated Z-0905-2013
- Terminated Z-0903-2013
- Terminated Z-0904-2013
It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications.
Specification
- Generic Name
- Craniofacial bone distractor extension
- Model / Ref / Catalog
- 487.976, 487976
- Primary DI / UDI-DI
- 10887587055909
- 510(k) Number
- FDA Product Code
- DZL
- GMDN Term
- Craniofacial bone distractor extension
- Device Class
- Class II
- Regulation Number
- 872.4880
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Other devices from Synthes
Properties
Other properties (10)
- Sterile: 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