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510(k) K830255

OSTEOTOMY BONE STAPLE by Techmedica, Inc. — Product Code HXJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 1983
Date Received
January 25, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Staple Driver
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type

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  • K911058 — TECHMEDICA CAD/CAM CUSTOM HIP (February 23, 1993)
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  • K920080 — CONTINUUM KNEE SYSTEM (September 1, 1992)

Other clearances for product code HXJ

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  • K834515 — FIXATION STAPLE KIT - DLIDE HAMMER (April 23, 1984)
  • K830456 — STAPLE INSERTER-EXTRACTOR FOR ARTHROS (March 9, 1983)