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FDA 510(k), K951355, LINK SADDLE PROTHESIS
FDA 510(k), K951355, LINK SADDLE PROTHESIS
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510(K) Number: K951355
Device Name: LINK SADDLE PROTHESIS
Manufacturer: TURNKEY INTERGRATION USA, INC.
Device Classification Name: prosthesis, hip, hemi-, femoral, metal
Regulation Number: 888.3360
Classification Product Code: KWL
Date Received: 03/08/1995
Decision Date: 05/25/1995
Regulation Medical Specialty: Orthopedic
Device Name: LINK SADDLE PROTHESIS
Manufacturer: TURNKEY INTERGRATION USA, INC.
Device Classification Name: prosthesis, hip, hemi-, femoral, metal
Regulation Number: 888.3360
Classification Product Code: KWL
Date Received: 03/08/1995
Decision Date: 05/25/1995
Regulation Medical Specialty: Orthopedic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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