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510(k) K920037

OSTEO COMPRESSION HIP SCREW by Osteo AG — Product Code HRC

K920037 is an FDA 510(k) premarket notification submitted by Osteo AG for the device "OSTEO COMPRESSION HIP SCREW". The FDA issued a decision of Substantially Equivalent on March 11, 1992. The device falls under product code HRC (Sterilizer, Soft-Lens, Thermal, Battery-Powered), a Class II device regulated under 21 CFR 886.5928. Osteo AG has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1992
Date Received
January 6, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilizer, Soft-Lens, Thermal, Battery-Powered
Device Class
Class II
Regulation Number
886.5928
Review Panel
OP
Submission Type

Other clearances by Osteo AG

  • K933340 — OSTEO INTERLOCKING-COMPRESSION NAIL (June 30, 1994)
  • K922195 — OSTEO FEMORAL NAIL (July 23, 1992)
  • K922196 — OSTEO TIBIA NAIL (July 23, 1992)
  • K922193 — OSTEO KIRSCHNER WIRE (July 23, 1992)
  • K922194 — OSTEO STEINMANN PIN (July 23, 1992)
  • K920149 — OSTEO EX-FI-RE (April 9, 1992)
  • K914374 — OSTEO CERCLAGE WIRE (December 30, 1991)
  • K913559 — OSTEO COMPLETE PNEUMATIC DRILL-OSCILAIR (November 7, 1991)

FDA data resources