The following data is part of a premarket notification filed by Core Essence Orthopaedics, Llc with the FDA for Renovo Suture Anchors, Models 100-2001 Thru 100-5502x.
| Device ID | K071520 |
| 510k Number | K071520 |
| Device Name: | RENOVO SUTURE ANCHORS, MODELS 100-2001 THRU 100-5502X |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | CORE ESSENCE ORTHOPAEDICS, LLC 301 OXFORD VALLEY RD. SUITE 905B Yardley, PA 19067 |
| Contact | Shawn T Huxel |
| Correspondent | Shawn T Huxel CORE ESSENCE ORTHOPAEDICS, LLC 301 OXFORD VALLEY RD. SUITE 905B Yardley, PA 19067 |
| Product Code | MBI |
| Subsequent Product Code | HWC |
| Subsequent Product Code | JDR |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-04 |
| Decision Date | 2007-08-10 |
| Summary: | summary |