The following data is part of a premarket notification filed by Smith & Nephew Richards, Inc. with the FDA for Genesis Constrained System (gcs).
| Device ID | K952271 |
| 510k Number | K952271 |
| Device Name: | GENESIS CONSTRAINED SYSTEM (GCS) |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | SMITH & NEPHEW RICHARDS, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Thomas L Craig |
| Correspondent | Thomas L Craig SMITH & NEPHEW RICHARDS, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-15 |
| Decision Date | 1995-09-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03596010184979 | K952271 | 000 |
| 03596010184726 | K952271 | 000 |
| 03596010184757 | K952271 | 000 |
| 03596010184764 | K952271 | 000 |
| 03596010184856 | K952271 | 000 |
| 03596010184733 | K952271 | 000 |
| 03596010184740 | K952271 | 000 |
| 03596010184788 | K952271 | 000 |
| 03596010184795 | K952271 | 000 |
| 03596010184801 | K952271 | 000 |
| 03596010184665 | K952271 | 000 |