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510(k) K853524

APR REVISION HIP PROSTHESIS, FEMORAL COMPONENT by Intermedics Orthopedics — Product Code KMC

K853524 is an FDA 510(k) premarket notification submitted by Intermedics Orthopedics for the device "APR REVISION HIP PROSTHESIS, FEMORAL COMPONENT". The FDA issued a decision of SN on November 22, 1985. The device falls under product code KMC (Prosthesis, Hip, Semi-Constrained, Composite/Metal), a Class II device regulated under 21 CFR 888.3340. Intermedics Orthopedics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
November 22, 1985
Date Received
August 22, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Composite/Metal
Device Class
Class II
Regulation Number
888.3340
Review Panel
OR
Submission Type

Other clearances by Intermedics Orthopedics

  • K970300 — NATURAL-HIP SYSTEM POROUS STEM WITH HA/CSTI (July 3, 1997)
  • K970498 — NATURAL-KNEE II REVISION FEMORAL SPACER LUGS (April 30, 1997)
  • K970166 — NATURAL-HIP SYSTEM COCR REVISION STEM (April 8, 1997)
  • K970567 — SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDS (February 27, 1997)
  • K964357 — NATURAL-HIP SYSTEM COCR STEM (January 27, 1997)
  • K964350 — MODULA OPTIONS FOR SEVERE BONE LOSS AND TRAUMA (January 16, 1997)
  • K962190 — PATELLOFEMORAL JOINT PROSTHESIS (October 28, 1996)
  • K963266 — NATURAL HIP SYSTEM POROUS STEM - COLLARLESS, COLLARED (October 15, 1996)
  • K963155 — INTERMOORE FRACTURE HIP STEM (MODIFY) (October 1, 1996)
  • K962315 — SELECT SHOULDER COCR HUMERAL STEM COMPONENT (September 3, 1996)

Other clearances for product code KMC

  • K936044 — ENHANCED MODULAR AUSTIN MOORE HIP (April 26, 1994)
  • K853259 — MALLORY/HEAD TOTAL HIP SYSTEM (November 1, 1985)

FDA data resources