WASHER, BOLT, NUT, ORTHOPEDIC— 510(k) K954682
Substantially Equivalent for Some IndicationsLinvatec Corp.
FDA 510(k) clearance K954682 for WASHER, BOLT, NUT, ORTHOPEDIC, Substantially Equivalent for Some Indications on 1996-02-09. Applicant: Linvatec Corp.. Device class: 2.
Clearance details
- Applicant
- Linvatec Corp.
- Product code
- Code HTN
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Largo, FL, US
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Adverse events under product code HTN
product code HTN- Injury
- 310
- Malfunction
- 639
- Total
- 949
Source: openFDA MAUDE database, through . 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.