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 5mm Model Ta1005, Anchor Inserter/suture Organizer 5mm Ai1005, Stabilizer Drill 5mm Nonste.
| Device ID | K973031 |
| 510k Number | K973031 |
| Device Name: | STABILIZER SOFT TISSUE ANCHOR 5MM MODEL TA1005, ANCHOR INSERTER/SUTURE ORGANIZER 5MM AI1005, STABILIZER DRILL 5MM NONSTE |
| Classification | Orthosis, Truncal/orthosis, Limb |
| 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 | MRI |
| CFR Regulation Number | 890.3490 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-14 |
| Decision Date | 1997-11-03 |
| Summary: | summary |