The following data is part of a premarket notification filed by Stryker Orthopaedics with the FDA for Dall-miles System.
| Device ID | K070170 |
| 510k Number | K070170 |
| Device Name: | DALL-MILES SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | STRYKER ORTHOPAEDICS 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Patricia Setti-laperch |
| Correspondent | Patricia Setti-laperch STRYKER ORTHOPAEDICS 325 Corporate Drive Mahwah, NJ 07430 |
| Product Code | HRS |
| Subsequent Product Code | JDQ |
| Subsequent Product Code | LYT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-18 |
| Decision Date | 2007-03-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613154490325 | K070170 | 000 |
| 04546540568090 | K070170 | 000 |
| 04546540568106 | K070170 | 000 |
| 04546540568113 | K070170 | 000 |
| 04546540568120 | K070170 | 000 |
| 04546540568137 | K070170 | 000 |
| 04546540568144 | K070170 | 000 |
| 04546540568151 | K070170 | 000 |
| 04546540568168 | K070170 | 000 |
| 07613154490240 | K070170 | 000 |
| 07613154490257 | K070170 | 000 |
| 07613154490264 | K070170 | 000 |
| 07613154490271 | K070170 | 000 |
| 07613154490288 | K070170 | 000 |
| 07613154490295 | K070170 | 000 |
| 07613154490301 | K070170 | 000 |
| 07613154490318 | K070170 | 000 |
| 04546540568083 | K070170 | 000 |