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FDA 510(k), K002552, HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE
FDA 510(k), K002552, HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE
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510(K) Number: K002552
Device Name: HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE
Manufacturer: HOWMEDICA OSTEONICS CORP.
Device Classification Name: prosthesis, knee, femorotibial, constrained, cemented, metal/polymer
Regulation Number: 888.3510
Classification Product Code: KRO
Date Received: 08/17/2000
Decision Date: 11/13/2000
Regulation Medical Specialty: Orthopedic
Device Name: HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE
Manufacturer: HOWMEDICA OSTEONICS CORP.
Device Classification Name: prosthesis, knee, femorotibial, constrained, cemented, metal/polymer
Regulation Number: 888.3510
Classification Product Code: KRO
Date Received: 08/17/2000
Decision Date: 11/13/2000
Regulation Medical Specialty: Orthopedic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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