The following data is part of a premarket notification filed by Extremity Medical, Llc. with the FDA for Kinematx Total Wrist Arthroplasty System.
| Device ID | K191525 |
| 510k Number | K191525 |
| Device Name: | KinematX Total Wrist Arthroplasty System |
| Classification | Prosthesis, Wrist, 3 Part Metal-plastic-metal Articulation, Semi-constrained |
| Applicant | Extremity Medical, LLC. 300 Interpace Parkway, Suite 410 Parsippany, NJ 07054 |
| Contact | Brian Smekal |
| Correspondent | Brian Smekal Extremity Medical, LLC. 300 Interpace Parkway, Suite 410 Parsippany, NJ 07054 |
| Product Code | JWJ |
| CFR Regulation Number | 888.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-10 |
| Decision Date | 2020-03-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842078120019 | K191525 | 000 |
| 00842078116838 | K191525 | 000 |
| 00842078116814 | K191525 | 000 |
| 00842078112090 | K191525 | 000 |
| 00842078112045 | K191525 | 000 |
| 00842078112038 | K191525 | 000 |
| 00842078112021 | K191525 | 000 |
| 00842078112014 | K191525 | 000 |
| 00842078111536 | K191525 | 000 |
| 00842078111529 | K191525 | 000 |
| 00842078116852 | K191525 | 000 |
| 00842078116876 | K191525 | 000 |
| 00842078120002 | K191525 | 000 |
| 00842078119990 | K191525 | 000 |
| 00842078119983 | K191525 | 000 |
| 00842078117033 | K191525 | 000 |
| 00842078117002 | K191525 | 000 |
| 00842078116999 | K191525 | 000 |
| 00842078116968 | K191525 | 000 |
| 00842078116937 | K191525 | 000 |
| 00842078116906 | K191525 | 000 |
| 00842078111512 | K191525 | 000 |