The following data is part of a premarket notification filed by Nexa Orthopedics, Inc. with the FDA for Subtalar Arthrorisis Implant.
Device ID | K032902 |
510k Number | K032902 |
Device Name: | SUBTALAR ARTHRORISIS IMPLANT |
Classification | Screw, Fixation, Bone |
Applicant | NEXA ORTHOPEDICS, INC. 990 PARK CENTER DR., SUITE H Vista, CA 92083 |
Contact | Louise M Focht |
Correspondent | Louise M Focht NEXA ORTHOPEDICS, INC. 990 PARK CENTER DR., SUITE H Vista, CA 92083 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-09-17 |
Decision Date | 2003-12-15 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00846832006335 | K032902 | 000 |
00846832006328 | K032902 | 000 |
00846832006311 | K032902 | 000 |
00846832006304 | K032902 | 000 |
00846832006298 | K032902 | 000 |
00846832006281 | K032902 | 000 |