The following data is part of a premarket notification filed by R. Thomas Grotz, M.d., Inc. with the FDA for Stabilizer Soft Tissue Anchor Model Number Ta1005, Ta1008, Anchor Inserter/suture Organizer Model Numbers Ai1005, Ai1008.
| Device ID | K965111 |
| 510k Number | K965111 |
| Device Name: | STABILIZER SOFT TISSUE ANCHOR MODEL NUMBER TA1005, TA1008, ANCHOR INSERTER/SUTURE ORGANIZER MODEL NUMBERS AI1005, AI1008 |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | R. THOMAS GROTZ, M.D., INC. 530 BUSH STREET, 10TH FLOOR San Francisco, CA 94108 |
| Contact | R. Thomas Grotz |
| Correspondent | R. Thomas Grotz R. THOMAS GROTZ, M.D., INC. 530 BUSH STREET, 10TH FLOOR San Francisco, CA 94108 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-20 |
| Decision Date | 1997-02-18 |
| Summary: | summary |