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510(k) K933340

OSTEO INTERLOCKING-COMPRESSION NAIL by Osteo AG — Product Code HSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 1994
Date Received
July 8, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rod, Fixation, Intramedullary And Accessories
Device Class
Class II
Regulation Number
888.3020
Review Panel
OR
Submission Type

Other clearances by Osteo AG

  • K922194 — OSTEO STEINMANN PIN (July 23, 1992)
  • K922193 — OSTEO KIRSCHNER WIRE (July 23, 1992)
  • K922195 — OSTEO FEMORAL NAIL (July 23, 1992)
  • K922196 — OSTEO TIBIA NAIL (July 23, 1992)
  • K920149 — OSTEO EX-FI-RE (April 9, 1992)
  • K920037 — OSTEO COMPRESSION HIP SCREW (March 11, 1992)
  • K914374 — OSTEO CERCLAGE WIRE (December 30, 1991)
  • K913559 — OSTEO COMPLETE PNEUMATIC DRILL-OSCILAIR (November 7, 1991)

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