The following data is part of a premarket notification filed by Nexa Orthopedics, Inc. with the FDA for Nexfix Compression Pin.
Device ID | K072710 |
510k Number | K072710 |
Device Name: | NEXFIX COMPRESSION PIN |
Classification | Pin, Fixation, Threaded |
Applicant | NEXA ORTHOPEDICS, INC. 11035 ROSELLE STREET San Diego, CA 92121 |
Contact | Corey Wilson-wirth |
Correspondent | Corey Wilson-wirth NEXA ORTHOPEDICS, INC. 11035 ROSELLE STREET San Diego, CA 92121 |
Product Code | JDW |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-09-25 |
Decision Date | 2007-11-08 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00846832007059 | K072710 | 000 |
00846832006977 | K072710 | 000 |
00846832006984 | K072710 | 000 |
00846832006991 | K072710 | 000 |
00846832007004 | K072710 | 000 |
00846832007011 | K072710 | 000 |
00846832007028 | K072710 | 000 |
00846832007035 | K072710 | 000 |
00846832007042 | K072710 | 000 |
00846832006960 | K072710 | 000 |