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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K931488
Device Name KSF SPINAL FIXATOR
Applicant
Franklin Medical USA, Inc.
1000 Burnett Ave.
Suite 250
Concord,  CA  94520
Applicant Contact DAVID W SCHLERF
Correspondent
Franklin Medical USA, Inc.
1000 Burnett Ave.
Suite 250
Concord,  CA  94520
Correspondent Contact DAVID W SCHLERF
Date Received03/25/1993
Decision Date 01/21/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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