The following data is part of a premarket notification filed by Trilliant Surgical Ltd with the FDA for Gridlock Plating System.
Device ID | K121452 |
510k Number | K121452 |
Device Name: | GRIDLOCK PLATING SYSTEM |
Classification | Plate, Fixation, Bone |
Applicant | TRILLIANT SURGICAL LTD 1001 OAKWOOD BLVD Round Rock, TX 78681 |
Contact | J.d. Webb |
Correspondent | J.d. Webb TRILLIANT SURGICAL LTD 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 | 2012-05-16 |
Decision Date | 2012-08-20 |
Summary: | summary |