The following data is part of a premarket notification filed by Orthomet, Inc. with the FDA for Orthomet Pin System.
Device ID | K874913 |
510k Number | K874913 |
Device Name: | ORTHOMET PIN SYSTEM |
Classification | Pin, Fixation, Smooth |
Applicant | ORTHOMET, INC. 6301 CECILIA CIRCLE Minneapolis, MN 55439 -2713 |
Contact | Al Lippincott |
Correspondent | Al Lippincott ORTHOMET, INC. 6301 CECILIA CIRCLE Minneapolis, MN 55439 -2713 |
Product Code | HTY |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-12-03 |
Decision Date | 1988-01-07 |