TRIDENT ACETABULAR SHELLS: PS-HA— 510(k) K001448
Substantially EquivalentHowmedica Osteonics Corp.
FDA 510(k) clearance K001448 for TRIDENT ACETABULAR SHELLS: PS-HA, Substantially Equivalent on 2000-08-04. Applicant: Howmedica Osteonics Corp.. Device class: 2.
Clearance details
- Applicant
- Howmedica Osteonics Corp.
- Product code
- Code MEH
- Device class
- Class 2
- Regulation
- 21 CFR 888.3353
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Allendale, NJ, US
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- K122015 — DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CIRCLIP, WEDGE
Adverse events under product code MEH
product code MEH- Injury
- 2,021
- Total
- 2,021
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.