The following data is part of a premarket notification filed by Nexa Orthopedics, Inc. with the FDA for Nexfix Compression Staple.
| Device ID | K070688 |
| 510k Number | K070688 |
| Device Name: | NEXFIX COMPRESSION STAPLE |
| Classification | Staple, Fixation, Bone |
| Applicant | NEXA ORTHOPEDICS, INC. 11035 ROSELLE STREET San Diego, CA 92121 |
| Contact | Louise M Focht |
| Correspondent | Louise M Focht NEXA ORTHOPEDICS, INC. 11035 ROSELLE STREET San Diego, CA 92121 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-12 |
| Decision Date | 2007-05-18 |
| Summary: | summary |