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 |