FDA 510(k), K032522, TECRES SPACER-K TEMPORARY KNEE PROSTHESIS
FDA 510(k), K032522, TECRES SPACER-K TEMPORARY KNEE PROSTHESIS
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510(K) Number: K032522
Device Name: TECRES SPACER-K TEMPORARY KNEE PROSTHESIS
Manufacturer: EXACTECH, INC.
Device Classification Name: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
Regulation Number: 888.3560
Classification Product Code: JWH
Date Received: 08/15/2003
Decision Date: 05/28/2004
Regulation Medical Specialty: Orthopedic
Device Name: TECRES SPACER-K TEMPORARY KNEE PROSTHESIS
Manufacturer: EXACTECH, INC.
Device Classification Name: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
Regulation Number: 888.3560
Classification Product Code: JWH
Date Received: 08/15/2003
Decision Date: 05/28/2004
Regulation Medical Specialty: Orthopedic
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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