PRELOADED SOFT TISSUE ANCHOR— 510(k) K953954

Substantially Equivalent for Some Indications

Linvatec Corp.

FDA 510(k) clearance K953954 for PRELOADED SOFT TISSUE ANCHOR, Substantially Equivalent for Some Indications on 1996-02-20. Applicant: Linvatec Corp..

Clearance details

Applicant: Linvatec Corp.
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 1995-08-22
Decision date: 1996-02-20
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Largo, FL, 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.