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FDA 510(k), K101356, Spacer-G and Spacer-K
FDA 510(k), K101356, Spacer-G and Spacer-K
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510(K) Number: K101356
Device Name: Spacer-G and Spacer-K
Manufacturer: TECRES SPA
Device Classification Name: prosthesis, hip, hemi-, femoral, metal
Regulation Number: 888.3360
Classification Product Code: KWL
Date Received: 05/14/2010
Decision Date: 09/20/2011
Regulation Medical Specialty: Orthopedic
Device Name: Spacer-G and Spacer-K
Manufacturer: TECRES SPA
Device Classification Name: prosthesis, hip, hemi-, femoral, metal
Regulation Number: 888.3360
Classification Product Code: KWL
Date Received: 05/14/2010
Decision Date: 09/20/2011
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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