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510(k) K901626

H.N. METAL BACKED ACETABULAR CUP, NONCEMENTED by Med-Tek Corp. — Product Code KWA

K901626 is an FDA 510(k) premarket notification submitted by Med-Tek Corp. for the device "H.N. METAL BACKED ACETABULAR CUP, NONCEMENTED". The FDA issued a decision of Substantially Equivalent on August 14, 1990. The device falls under product code KWA (Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)), a Class III device regulated under 21 CFR 888.3330. Med-Tek Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 1990
Date Received
April 9, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Device Class
Class III
Regulation Number
888.3330
Review Panel
OR
Submission Type

Other clearances by Med-Tek Corp.

  • K903234 — F-19 TOTAL HIP PROSTHESIS (October 10, 1990)
  • K901687 — F-24 FEMORAL HIP PROSTHESIS (September 7, 1990)
  • K901451 — F-20 CEMENTED METAL-BACKED ACETABULAR CUP (August 31, 1990)
  • K900428 — ANESTHESIA BREATHING CIRCUITS (August 17, 1990)
  • K901594 — H.N. TOTAL HIP PROSTHESIS (August 3, 1990)
  • K901480 — F-20 TOTAL HIP PROSTHESIS (June 12, 1990)
  • K901273 — L.M.S. SELF-DETACHABLE BROACH WITH STOP (June 5, 1990)
  • K901272 — ORION BLADE PLATE FOR TIBIAL OSTEOTOMY (April 23, 1990)
  • K901240 — ASTEL NON-METAL BACKED ACETABULAR CUP FOR CEMENTED (March 26, 1990)
  • K894978 — BACTERIAL FILTER (November 2, 1989)

Other clearances for product code KWA

  • K122778 — PROFEMUR Z REVISION HIP STEM (October 11, 2012)
  • K121544 — DYNASTY BIOFOAM SHELL (July 30, 2012)
  • K113271 — METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS (May 18, 2012)
  • K113322 — CONSERVE THIN SHELL (February 3, 2012)
  • K112080 — PRESERVE HIP STEM (December 28, 2011)
  • K112150 — PROFEMUR GLADIATOR HA HIP STEM (November 23, 2011)
  • K113019 — PROFEMUR XM WINGLESS DISTAL CENTRALIZER, PERFECTA DISTAL CENTRALIZER (November 10, 2011)
  • K111910 — GLADIATOR HIP STEM (October 14, 2011)
  • K110836 — CLS BREVIUS STEM WITH KINECTIV TECHNOLOGY (October 7, 2011)
  • K110400 — TAPERLOC COMPLETE MICROPLASTY STEM (September 30, 2011)

FDA data resources