The following data is part of a premarket notification filed by Stryker with the FDA for Stryker Iconix With Needles.
Device ID | K151201 |
510k Number | K151201 |
Device Name: | Stryker ICONIX With Needles |
Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
Applicant | Stryker 5670 Greenwood Plaza Blvd, Suite 200 Greenwood Village, CO 80111 |
Contact | Taylor White |
Correspondent | Taylor White Stryker 5670 Greenwood Plaza Blvd, Suite 200 Greenwood Village, CO 80111 |
Product Code | MBI |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-05-05 |
Decision Date | 2015-06-29 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
37613327283465 | K151201 | 000 |
37613327283458 | K151201 | 000 |
37613327283441 | K151201 | 000 |
37613327283434 | K151201 | 000 |