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, 5 And 8mm; Anchor Inserter, 5 And 8mm; Stabilizer Drill, 5 And 8mm, Nonsterile; Stabilize.
| Device ID | K984200 |
| 510k Number | K984200 |
| Device Name: | STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM; ANCHOR INSERTER, 5 AND 8MM; STABILIZER DRILL, 5 AND 8MM, NONSTERILE; STABILIZE |
| 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 | 1998-11-24 |
| Decision Date | 1999-01-21 |
| Summary: | summary |