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510(k) K970166

NATURAL-HIP SYSTEM COCR REVISION STEM by Intermedics Orthopedics — Product Code LZO

K970166 is an FDA 510(k) premarket notification submitted by Intermedics Orthopedics for the device "NATURAL-HIP SYSTEM COCR REVISION STEM". The FDA issued a decision of Substantially Equivalent on April 8, 1997. The device falls under product code LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented), a Class II device regulated under 21 CFR 888.3353. Intermedics Orthopedics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 1997
Date Received
January 16, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Device Class
Class II
Regulation Number
888.3353
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)
  • 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)
  • K962289 — SELECT SHOULDER COCR HUMERAL STEM COMPONENT (August 29, 1996)

Other clearances for product code LZO

  • K261009 — MobileLink Acetabular Cup System – 40mm ID Inserts (various) (July 6, 2026)
  • K260831 — Z1 Hip System (June 16, 2026)
  • K260182 — Avenir® Müller Stem; Avenir Complete™ Hip System (April 27, 2026)
  • K260037 — implantcast Packaging System Update (March 30, 2026)
  • K252401 — implaFit® short stems (March 12, 2026)
  • K253171 — Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem) (January 15, 2026)
  • K250450 — Coated hip implants (September 19, 2025)
  • K243021 — Longboard Revision Hip Stem (August 7, 2025)
  • K251906 — Z1 Hip System (July 18, 2025)
  • K251292 — RECLAIM Monobloc Revision Femoral Stem (May 23, 2025)

FDA data resources