The following data is part of a premarket notification filed by Core Essence Orthopaedics, Llc with the FDA for Reverto 55 And 37 Shape Memory Staples.
| Device ID | K071477 |
| 510k Number | K071477 |
| Device Name: | REVERTO 55 AND 37 SHAPE MEMORY STAPLES |
| Classification | Staple, Fixation, Bone |
| 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 | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-29 |
| Decision Date | 2007-08-15 |
| Summary: | summary |