The following data is part of a premarket notification filed by Pontis Orthopaedics, Llc with the FDA for Multifilament Stainless Steel Sutures With Crimps.
| Device ID | K133579 |
| 510k Number | K133579 |
| Device Name: | MULTIFILAMENT STAINLESS STEEL SUTURES WITH CRIMPS |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | PONTIS ORTHOPAEDICS, LLC 2229 POST STREET, SUITE 103 San Francisco, CA 94115 |
| Contact | Leonard Gordon |
| Correspondent | Leonard Gordon PONTIS ORTHOPAEDICS, LLC 2229 POST STREET, SUITE 103 San Francisco, CA 94115 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-21 |
| Decision Date | 2014-06-26 |
| Summary: | summary |