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510(k) K925181

TECHMEDICA MUELLER TYPE POLYETHYLENE ACETBUL CUP by Techmedica, Inc. — Product Code JDL

K925181 is an FDA 510(k) premarket notification submitted by Techmedica, Inc. for the device "TECHMEDICA MUELLER TYPE POLYETHYLENE ACETBUL CUP". The FDA issued a decision of Substantially Equivalent on February 5, 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. Techmedica, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 1993
Date Received
October 14, 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 Techmedica, Inc.

  • K933935 — CKS POROUS COATED FEMORAL COMPONENT (October 11, 1994)
  • K932017 — TECHMEDICA CONTINUUM HIP WITH HA COATING (September 1, 1994)
  • K931929 — TECHMEDICA CONTINUUM HIP SYSTEM (March 29, 1994)
  • K926387 — TECHMEDICA STANDARD CEMENTED HIP SYSTEM (February 1, 1994)
  • K925420 — TECHMEDICA STANDARD BIPOLAR SYSTEM (September 28, 1993)
  • K923808 — MULLER STRAIGHT STEM FEMORAL PROSTHESIS (July 27, 1993)
  • K926579 — TECHMEDICA 6.5MM SELF-TAPPING CANCELLOUS BONE SCRE (April 6, 1993)
  • K911058 — TECHMEDICA CAD/CAM CUSTOM HIP (February 23, 1993)
  • K920080 — CONTINUUM KNEE SYSTEM (September 1, 1992)
  • K921458 — TMP MICROPLATING SYSTEM (July 17, 1992)

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