The following data is part of a premarket notification filed by Stryker Cmf with the FDA for Stryker External Fixation System.
| Device ID | K071628 |
| 510k Number | K071628 |
| Device Name: | STRYKER EXTERNAL FIXATION SYSTEM |
| Classification | External Mandibular Fixator And/or Distractor |
| Applicant | STRYKER CMF 750 TRADE CENTRE WAY SUITE 200 Kalamazoo, MI 49001 |
| Contact | Tennille Folk |
| Correspondent | Tennille Folk STRYKER CMF 750 TRADE CENTRE WAY SUITE 200 Kalamazoo, MI 49001 |
| Product Code | MQN |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-14 |
| Decision Date | 2007-08-10 |
| Summary: | summary |