The following data is part of a premarket notification filed by Kinamed, Inc. with the FDA for Gem Knee System.
| Device ID | K994214 |
| 510k Number | K994214 |
| Device Name: | GEM KNEE SYSTEM |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | KINAMED, INC. 9229 CRANFORD DR. Potomac, MD 20854 |
| Contact | Joel Slomoff |
| Correspondent | Joel Slomoff KINAMED, INC. 9229 CRANFORD DR. Potomac, MD 20854 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-14 |
| Decision Date | 2000-07-19 |