The following data is part of a premarket notification filed by Ziptek, Llc with the FDA for Zipe Knotless Tissue Repair And Attachment Devices.
| Device ID | K162429 |
| 510k Number | K162429 |
| Device Name: | ZipE Knotless Tissue Repair And Attachment Devices |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | ZIPTEK, LLC 1250 S TAMIAMI TRL STE 303 Sarasota, FL 34239 -2221 |
| Contact | William F. Bennett |
| Correspondent | Janice M. Hogan HOGAN LOVELLS US LLP 1835 MARKET ST 29TH FLOOR Philadelphia, PA 19103 |
| Product Code | MAI |
| Subsequent Product Code | KGS |
| Subsequent Product Code | MBI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-30 |
| Decision Date | 2017-03-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858816006002 | K162429 | 000 |
| 10858816006009 | K162429 | 000 |
| 10858816006061 | K162429 | 000 |
| 00858816006064 | K162429 | 000 |