| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | NATURAL-KNEE(R) AND NATURAL KNEE(R)II W/CSTI(TM) |
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| Generic Name | PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER |
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| Applicant | SULZERMEDICA
9900 SPECTRUM DR.
AUSTIN,, TX 78717 |
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| PMA Number | P940002 |
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| Date Received | 01/14/1994 |
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| Decision Date | 03/21/1997 |
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Reclassified Date
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02/01/2003 |
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| Product Code |
MBD |
| Docket Number | 97M-0252 |
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| Notice Date | 06/30/1997 |
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| Advisory Committee |
Orthopedic |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order Statement
APPROVAL FOR THE NATURAL-KNEE(R) AND NATURAL KNEE(R) II WITH CSTI(TM). THESE DEVICES ARE INDICATED FOR UNCEMENTED USE IN SKELETALLY MATURE INDIVIDUALS WITH INTACT MEDIAL AND LATERAL COLLATERAL LIGAMENTS UNDERGOING PRIMARY SURGERY FOR REHABILITATING KNEES DAMAGED AS A RESULT FO NONINFLAMMATORY DEGENERATIVE JOINT DISEASE (NIDJD) OR INFLAMMATORY JOINT DISEASE (IJD) |
| Supplements: |
S001 S002 S003 S005 |
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