The following data is part of a premarket notification filed by Pontis Orthopaeeics, Llc with the FDA for Pontis 3mm Suture Anchors With Ultra-high Molecular Weight Polyethylene Suture, Pontis Ultra-high Molecular Weight Polye.
| Device ID | K141711 |
| 510k Number | K141711 |
| Device Name: | PONTIS 3MM SUTURE ANCHORS WITH ULTRA-HIGH MOLECULAR WEIGHT POLYETHYLENE SUTURE, PONTIS ULTRA-HIGH MOLECULAR WEIGHT POLYE |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | PONTIS ORTHOPAEEICS, LLC 2299 POST STREET, SUITE 103 San Francisco, CA 94115 |
| Contact | Leonard Gordon |
| Correspondent | Leonard Gordon PONTIS ORTHOPAEEICS, LLC 2299 POST STREET, SUITE 103 San Francisco, CA 94115 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-25 |
| Decision Date | 2014-07-24 |
| Summary: | summary |