STERLING INTERFERENCE SCREW HT, STERLING INTERFERENCE SCREW ST.— 510(k) K060253

Substantially Equivalent

Regeneration Technologies, Inc.

FDA 510(k) clearance K060253 for STERLING INTERFERENCE SCREW HT, STERLING INTERFERENCE SCREW ST., Substantially Equivalent on 2006-02-23. Applicant: Regeneration Technologies, Inc..

Clearance details

Applicant: Regeneration Technologies, Inc.
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 2006-02-01
Decision date: 2006-02-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Alachua, FL, US

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Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

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.