The following data is part of a premarket notification filed by Stryker Sustainability Solutions with the FDA for Reprocessed Stryker External Fixation Devices.
| Device ID | K153415 |
| 510k Number | K153415 |
| Device Name: | Reprocessed Stryker External Fixation Devices |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | STRYKER SUSTAINABILITY SOLUTIONS 1810 W. DRAKE DRIVE Tempe, AZ 85283 |
| Contact | Kelli Dryer |
| Correspondent | Kelli Dryer STRYKER SUSTAINABILITY SOLUTIONS 1810 W. DRAKE DRIVE Tempe, AZ 85283 |
| Product Code | KTT |
| Subsequent Product Code | JEC |
| Subsequent Product Code | KTW |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-25 |
| Decision Date | 2016-01-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327323108 | K153415 | 000 |
| 07613327303520 | K153415 | 000 |
| 07613327303537 | K153415 | 000 |
| 07613327303544 | K153415 | 000 |
| 07613327303551 | K153415 | 000 |
| 07613327303568 | K153415 | 000 |
| 07613327303575 | K153415 | 000 |
| 07613327303582 | K153415 | 000 |
| 07613327303599 | K153415 | 000 |
| 07613327323078 | K153415 | 000 |
| 07613327323085 | K153415 | 000 |
| 07613327323092 | K153415 | 000 |
| 07613327303513 | K153415 | 000 |