The following data is part of a premarket notification filed by Nexa Orthopedics, Inc. with the FDA for Classic Great Toe Implant.
Device ID | K023086 |
510k Number | K023086 |
Device Name: | CLASSIC GREAT TOE IMPLANT |
Classification | Prosthesis, Toe, Constrained, Polymer |
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 | KWH |
CFR Regulation Number | 888.3720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-09-17 |
Decision Date | 2002-10-04 |
Summary: | summary |