The following data is part of a premarket notification filed by Orthopro Llc with the FDA for Dc Ulnar Shortening System.
Device ID | K073228 |
510k Number | K073228 |
Device Name: | DC ULNAR SHORTENING SYSTEM |
Classification | Plate, Fixation, Bone |
Applicant | ORTHOPRO LLC 1001 OAKWOOD BLVD. Round Rock, TX 78681 |
Contact | J.d. Webb |
Correspondent | J.d. Webb ORTHOPRO LLC 1001 OAKWOOD BLVD. Round Rock, TX 78681 |
Product Code | HRS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-11-15 |
Decision Date | 2008-02-29 |
Summary: | summary |