The following data is part of a premarket notification filed by Pontis Orthopaedics, Llc with the FDA for Ferrofibre Stainless Steel Suture With Crimp.
| Device ID | K140127 |
| 510k Number | K140127 |
| Device Name: | FERROFIBRE STAINLESS STEEL SUTURE WITH CRIMP |
| Classification | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile |
| Applicant | PONTIS ORTHOPAEDICS, LLC 2299 POST STREET, SUITE 103 San Francisco, CA 94115 |
| Contact | Leonard Gordon |
| Correspondent | Leonard Gordon PONTIS ORTHOPAEDICS, LLC 2299 POST STREET, SUITE 103 San Francisco, CA 94115 |
| Product Code | GAQ |
| CFR Regulation Number | 878.4495 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-16 |
| Decision Date | 2014-05-28 |
| Summary: | summary |