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510(k) K070928

CERAMIC BALL HEADS, 28, 32 AND 36 MM by Plus Orthopedics AG — Product Code LZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2007
Date Received
April 3, 2007
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 Plus Orthopedics AG

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  • K063578 — PROMOS MODULAR SHOULDER SYSTEM (March 2, 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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