The following data is part of a premarket notification filed by Nexa Orthopedics, Inc. with the FDA for Tapered Compression Pin.
Device ID | K051740 |
510k Number | K051740 |
Device Name: | TAPERED COMPRESSION PIN |
Classification | Pin, Fixation, Threaded |
Applicant | NEXA ORTHOPEDICS, INC. 990 PARK CENTER DR., SUITE H Vista, CA 92081 |
Contact | Louise M Focht |
Correspondent | Louise M Focht NEXA ORTHOPEDICS, INC. 990 PARK CENTER DR., SUITE H Vista, CA 92081 |
Product Code | JDW |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-06-28 |
Decision Date | 2005-09-06 |
Summary: | summary |