STABILIZER SOFT TISSUE ANCHOR, 8MM MODEL TA1008, ANCHOR INSERTER/SUTURE ORGANIZER, 8MM MODEL AI1008, STABILIZER DRILL, 8— 510(k) K964927

Substantially Equivalent

R. Thomas Grotz, M.D., Inc.

FDA 510(k) clearance K964927 for STABILIZER SOFT TISSUE ANCHOR, 8MM MODEL TA1008, ANCHOR INSERTER/SUTURE ORGANIZER, 8MM MODEL AI1008, STABILIZER DRILL, 8, Substantially Equivalent on 1997-02-07. Applicant: R. Thomas Grotz, M.D., Inc..

Clearance details

Applicant: R. Thomas Grotz, M.D., Inc.
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 1996-12-09
Decision date: 1997-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Francisco, CA, US

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Adverse events under product code MBI

product code MBI

Injury: 3,163
Malfunction: 13,006
Other: 2
Total: 16,171

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.