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FDA 510(k), K081232, TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH PRAXITELES
FDA 510(k), K081232, TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH PRAXITELES
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510(K) Number: K081232
Device Name: TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH PRAXITELES
Manufacturer: PRAXIM
Device Classification Name: neurological stereotaxic instrument
Regulation Number: 882.4560
Classification Product Code: HAW
Date Received: 05/01/2008
Decision Date: 08/06/2008
Regulation Medical Specialty: Neurology
Device Name: TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH PRAXITELES
Manufacturer: PRAXIM
Device Classification Name: neurological stereotaxic instrument
Regulation Number: 882.4560
Classification Product Code: HAW
Date Received: 05/01/2008
Decision Date: 08/06/2008
Regulation Medical Specialty: Neurology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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