The following data is part of a premarket notification filed by Core Essence Orthopaedics, Inc. with the FDA for Pontis Sutures And Suture Anchors With Optional Crimps.
| Device ID | K101126 |
| 510k Number | K101126 |
| Device Name: | PONTIS SUTURES AND SUTURE ANCHORS WITH OPTIONAL CRIMPS |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | CORE ESSENCE ORTHOPAEDICS, INC. 575A VIRGINIA DRIVE Ft Washington, PA 19034 |
| Contact | Jeff Miller |
| Correspondent | Jeff Miller CORE ESSENCE ORTHOPAEDICS, INC. 575A VIRGINIA DRIVE Ft Washington, PA 19034 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-22 |
| Decision Date | 2010-12-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859210006025 | K101126 | 000 |