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510(k) K080873

OPACITY + BONE CEMENT by Teknimed, S.A. — Product Code NDN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 2008
Date Received
March 31, 2008
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cement, Bone, Vertebroplasty
Device Class
Class II
Regulation Number
888.3027
Review Panel
OR
Submission Type

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  • K090435 — VERTECEM (December 21, 2009)
  • K083005 — NANGEL (March 4, 2009)
  • K062102 — ODONCER (April 16, 2007)
  • K043593 — SPINE-FIX BIOMIMETIC BONE CEMENT (March 17, 2006)
  • K042911 — CEMENTEK LV (December 27, 2004)

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