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510(k) K922861

BIOMETRIC SCREW FIXATION CUP by Osteo Technology, Inc. — Product Code JDL

K922861 is an FDA 510(k) premarket notification submitted by Osteo Technology, Inc. for the device "BIOMETRIC SCREW FIXATION CUP". The FDA issued a decision of Substantially Equivalent on May 12, 1993. The device falls under product code JDL (Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)), a Class III device regulated under 21 CFR 888.3320. Osteo Technology, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 1993
Date Received
June 4, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
Device Class
Class III
Regulation Number
888.3320
Review Panel
OR
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)
  • K922870 — THREE SPIKE CUP (April 8, 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 JDL

  • K073499 — VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIES (August 7, 2008)
  • K070785 — DYNASTY ACETABULAR SYSTEM (July 11, 2007)
  • K061844 — DYNASTY ACETABULAR SHELL AND COCR ACETABULAR LINER (December 6, 2006)
  • K051995 — PROFEMUR RENAISSANCE HIP STEM (August 22, 2005)
  • K051348 — CONSERVE TOTAL FEMORAL HEAD (August 19, 2005)
  • K042841 — M2A/C2A ACETABULAR SYSTEM (December 21, 2004)
  • K041586 — PROFEMUR S HIP STEM (July 9, 2004)
  • K041114 — PROFEMUR TAPERED HIP STEM (May 28, 2004)
  • K004043 — METAL TRANSCEND ARTICULATION SYSTEM (July 13, 2001)
  • K950542 — METAL BACKED ACETABULAR COMPONENT (May 25, 1995)

FDA data resources