Optical 20-8000-020-10
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00889024304840 | Date7 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK030827 | Date23 May 2003 | StatusActive |
Official records
- AccessGUDID record 00889024304840
- FDA 510(k) database K030827
Recalls
-
- Terminated Z-2445-2008
Inadequate weld on tracker, knob oversized and poor thread design on attachment screw results in seizing. The instrument may break during use, resulting in surgical delay and an increased risk of infection.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Optical
- Generic name
- Orthopaedic prosthesis implantation positioning instrument, reusable
- Model / Ref / Catalog
- 20-8000-020-10
- Primary DI / UDI-DI
- 00889024304840
- 510(k) Number
- FDA product code
- HAW
- GMDN term
- Orthopaedic prosthesis implantation positioning instrument, reusable
- Device class
- Class II
- Regulation number
- 882.4560
- GUDID distribution status
- Not in Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Other devices from Orthosoft Inc
Properties
Other properties (12)
- Supplied 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