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 |