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FDA 510(k), K062274, SPACER-K TEMPORARY KNEE SPACER WITH GENTAMICIN, MODELS SPK0021, SPK0121, SPK0221, SPK0321
FDA 510(k), K062274, SPACER-K TEMPORARY KNEE SPACER WITH GENTAMICIN, MODELS SPK0021, SPK0121, SPK0221, SPK0321
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510(K) Number: K062274
Device Name: SPACER-K TEMPORARY KNEE SPACER WITH GENTAMICIN, MODELS SPK0021, SPK0121, SPK0221, SPK0321
Manufacturer: TECRES SPA
Device Classification Name: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
Regulation Number: 888.3560
Classification Product Code: JWH
Date Received: 08/07/2006
Decision Date: 05/22/2008
Regulation Medical Specialty: Orthopedic
Device Name: SPACER-K TEMPORARY KNEE SPACER WITH GENTAMICIN, MODELS SPK0021, SPK0121, SPK0221, SPK0321
Manufacturer: TECRES SPA
Device Classification Name: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
Regulation Number: 888.3560
Classification Product Code: JWH
Date Received: 08/07/2006
Decision Date: 05/22/2008
Regulation Medical Specialty: Orthopedic
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