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510(k) K901456

ORTHOSORB(R) ABSORBABLE PIN by Johnson & Johnson International — Product Code OVZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 1990
Date Received
March 27, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pin, Fixation, Resorbable, Hard Tissue
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

Intended for small bone fixation in fracture, osteotomy, and arthrodesis applications.

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  • K942383 — DERMIVIEW CLEAR TAPE (August 22, 1994)
  • K922918 — BARRIER SAF-TE HYDROGEL DRAPE (July 6, 1993)
  • K923807 — P.F.C. MODULAR TOTAL KNEE SYSTEM, MODULAR PLUS (November 9, 1992)
  • K896828 — BIOCLUSIVE(R) ABSORBENT DRESSING (November 21, 1990)
  • K900638 — P.F.C. HIP SYSTEM NON-POROUS FEMORAL COMPONENT (April 30, 1990)
  • K895207 — BIOCLUSIVE* TRANSPARENT FILM DRESSING - NEW CLAIM (September 28, 1989)

Other clearances for product code OVZ

  • K140625 — ORTHOSORB LS (April 18, 2014)
  • K111077 — ORTHOSORB RESORBABLE PINS (July 12, 2011)