The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Newphew, Inc. Disposable Knee Instruments.
| Device ID | K123159 |
| 510k Number | K123159 |
| Device Name: | SMITH & NEWPHEW, INC. DISPOSABLE KNEE INSTRUMENTS |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Martin Ostmann |
| Correspondent | Martin Ostmann SMITH & NEPHEW, 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 | 2012-10-09 |
| Decision Date | 2013-05-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556616680 | K123159 | 000 |