The following data is part of a premarket notification filed by Zimmer with the FDA for Smarttools Knee System.
| Device ID | K122326 |
| 510k Number | K122326 |
| Device Name: | SMARTTOOLS KNEE SYSTEM |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | ZIMMER 75, QUEEN STREET SUITE 3300 Montreal, CA H3c 2n6 |
| Contact | Christopher Mclean |
| Correspondent | Christopher Mclean ZIMMER 75, QUEEN STREET SUITE 3300 Montreal, CA H3c 2n6 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-01 |
| Decision Date | 2012-11-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024305502 | K122326 | 000 |
| 00889024305342 | K122326 | 000 |
| 00889024305335 | K122326 | 000 |
| 00889024305328 | K122326 | 000 |
| 00889024305311 | K122326 | 000 |
| 00889024305304 | K122326 | 000 |
| 00889024305298 | K122326 | 000 |
| 00889024305281 | K122326 | 000 |
| 00889024305274 | K122326 | 000 |
| 00889024305267 | K122326 | 000 |
| 00889024305359 | K122326 | 000 |
| 00889024305366 | K122326 | 000 |
| 00889024305373 | K122326 | 000 |
| 00889024305465 | K122326 | 000 |
| 00889024305458 | K122326 | 000 |
| 00889024305441 | K122326 | 000 |
| 00889024305434 | K122326 | 000 |
| 00889024305427 | K122326 | 000 |
| 00889024305410 | K122326 | 000 |
| 00889024305403 | K122326 | 000 |
| 00889024305397 | K122326 | 000 |
| 00889024305380 | K122326 | 000 |
| 00889024305243 | K122326 | 000 |