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510(k) K922870

THREE SPIKE CUP by Osteo Technology, Inc. — Product Code GRF

K922870 is an FDA 510(k) premarket notification submitted by Osteo Technology, Inc. for the device "THREE SPIKE CUP". The FDA issued a decision of Substantially Equivalent on April 8, 1993. The device falls under product code GRF (Antiserum, Cf, Rubeola), a Class I device regulated under 21 CFR 866.3520. Osteo Technology, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 1993
Date Received
June 4, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antiserum, Cf, Rubeola
Device Class
Class I
Regulation Number
866.3520
Review Panel
MI
Submission Type

Other clearances by Osteo Technology, Inc.

  • K926156 — REPLICA(TM) TOTAL HIP SYSTEM (March 9, 1994)
  • K922859 — ANATOMICAL TYPE KNEE SYSTEM (September 23, 1993)
  • K922869 — TOTAL CONDYLAT TYPE KNEE SYSTEM (July 13, 1993)
  • K925447 — OTI ORTHOPEDIC WIRE SYSTEM (June 29, 1993)
  • K926213 — MODIFIED ZICKEL INTRAMEDULLARY ROD SYSTEM (June 17, 1993)
  • K922861 — BIOMETRIC SCREW FIXATION CUP (May 12, 1993)
  • K922682 — AMERICANA HIP PROTHESIS (March 16, 1993)
  • K925301 — OTI ORTHOPEDIC FASTENER SYSTEM (March 16, 1993)
  • K922871 — UNIFIT FEMORAL STEM (February 12, 1993)
  • K922864 — MUELLER TYPE FEMORAL STEM (February 12, 1993)

Other clearances for product code GRF

  • K852932 — MEASLES-COMPLEMENT FIX ANTIGEN & NEGATIVE CLT (November 12, 1985)

FDA data resources