The following data is part of a premarket notification filed by Trilliant Surgical Ltd with the FDA for Tiger Cannulated Screw System.
| Device ID | K081510 |
| 510k Number | K081510 |
| Device Name: | TIGER CANNULATED SCREW SYSTEM |
| Classification | Screw, 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 | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-29 |
| Decision Date | 2008-08-04 |
| Summary: | summary |