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, 8mm Model Ta1008, Anchor Inserter/suture Organizer, 8mm Model Ai1008, Stabilizer Drill, 8.
| Device ID | K964927 |
| 510k Number | K964927 |
| Device Name: | STABILIZER SOFT TISSUE ANCHOR, 8MM MODEL TA1008, ANCHOR INSERTER/SUTURE ORGANIZER, 8MM MODEL AI1008, STABILIZER DRILL, 8 |
| 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 | 1996-12-09 |
| Decision Date | 1997-02-07 |
| Summary: | summary |