The following data is part of a premarket notification filed by Smith & Nephew Richards, Inc. with the FDA for Reflection Acetabular Reinforcement Rings.
| Device ID | K962541 |
| 510k Number | K962541 |
| Device Name: | REFLECTION ACETABULAR REINFORCEMENT RINGS |
| Classification | Mesh, Surgical, Acetabular, Hip, Prosthesis |
| Applicant | SMITH & NEPHEW RICHARDS, INC. 1450 E. BROOKS RD. Memphis, TN 38116 |
| Contact | Thomas L Graig |
| Correspondent | Thomas L Graig SMITH & NEPHEW RICHARDS, INC. 1450 E. BROOKS RD. Memphis, TN 38116 |
| Product Code | JDJ |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-28 |
| Decision Date | 1996-09-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03596010293305 | K962541 | 000 |
| 03596010293329 | K962541 | 000 |
| 03596010293336 | K962541 | 000 |
| 03596010293343 | K962541 | 000 |
| 03596010308290 | K962541 | 000 |
| 03596010308306 | K962541 | 000 |
| 03596010525178 | K962541 | 000 |
| 03596010527318 | K962541 | 000 |
| 03596010527325 | K962541 | 000 |
| 03596010527332 | K962541 | 000 |
| 03596010292032 | K962541 | 000 |
| 03596010292049 | K962541 | 000 |
| 03596010292056 | K962541 | 000 |
| 03596010292063 | K962541 | 000 |
| 03596010292070 | K962541 | 000 |
| 03596010292087 | K962541 | 000 |
| 03596010293282 | K962541 | 000 |
| 03596010293299 | K962541 | 000 |
| 03596010293312 | K962541 | 000 |