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510(k) K063578

PROMOS MODULAR SHOULDER SYSTEM by Plus Orthopedics AG — Product Code HSD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 2007
Date Received
November 30, 2006
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

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  • K070278 — POLARCUP DUAL MOBILITY SYSTEM (April 16, 2007)
  • K061362 — PIGALILEO TOTAL KNEE REPLACEMENT (TKR) SYSTEM (October 6, 2006)
  • K032126 — PROMOS SHOULDER (January 8, 2004)
  • K033763 — MODIFICATION TO SLIM GLIDING NAIL SYSTEM (December 18, 2003)
  • K032709 — MODULAR PLUS HIP STEM (September 23, 2003)
  • K032548 — IP-XS COMPRESSION NAIL SYSTEM (September 10, 2003)
  • K032215 — VKS/TC-PLUS REVISION KNEE (August 8, 2003)
  • K032052 — UC-PLUS SOLUTION UNICONDYLAR KNEE (July 25, 2003)

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  • K161782 — Arthrex Univers Revers Shoulder Prosthesis System (November 21, 2016)
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  • K142942 — HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System (December 19, 2014)
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