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510(k) K092773

CEMEX GENTA, GENTA SYSTEM AND GENTA SYSTEM FAST by Tecres S.P.A. — Product Code LOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 2009
Date Received
September 9, 2009
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Tecres S.P.A.

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  • K122175 — MENDEC SPINE HV, MENDEC SPINE HV SYSTEM (March 28, 2013)
  • K112983 — SPACER-S (December 12, 2011)
  • K101356 — Spacer-G and Spacer-K (September 20, 2011)
  • K062274 — SPACER-K TEMPORARY KNEE SPACER WITH GENTAMICIN, MODELS SPK0021, SPK0121, SPK0221 (May 22, 2008)
  • K062273 — SPACER-G TEMPORARY HIP PROSTHESIS (May 22, 2008)
  • K063438 — VSPSPN (January 17, 2007)

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