Home / 510(k) Clearances / K962289

510(k) K962289

SELECT SHOULDER COCR HUMERAL STEM COMPONENT by Intermedics Orthopedics — Product Code HSD

K962289 is an FDA 510(k) premarket notification submitted by Intermedics Orthopedics for the device "SELECT SHOULDER COCR HUMERAL STEM COMPONENT". The FDA issued a decision of Substantially Equivalent on August 29, 1996. The device falls under product code HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented), a Class II device regulated under 21 CFR 888.3690. Intermedics Orthopedics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 1996
Date Received
June 14, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Device Class
Class II
Regulation Number
888.3690
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 HSD

  • K233260 — Univers Revers CA Head and Adapter (February 12, 2024)
  • K221232 — Univers Revers Humeral Cup Implant (May 19, 2022)
  • K191433 — AGILON® XO Shoulder Replacement System (November 12, 2020)
  • K193122 — Biocore9 Humeral Resurfacing System (May 15, 2020)
  • K173964 — OVOMotion Shoulder Arthroplasty System (April 18, 2018)
  • K161782 — Arthrex Univers Revers Shoulder Prosthesis System (November 21, 2016)
  • K161620 — Anatomical Shoulder Domelock Dome centric (November 1, 2016)
  • K151527 — Arthrex Univers Revers CA Heads and Adapters (April 19, 2016)
  • K142942 — HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System (December 19, 2014)
  • K131298 — EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM (November 26, 2013)

FDA data resources