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510(k) K043172

TRUGRAFT BGS SYRINGE, MODEL 600-041 by Osteobiologics, Inc. — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 2005
Date Received
November 16, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type

Other clearances by Osteobiologics, Inc.

  • K051656 — OCT (OSTEOCHONDRAL TRANSPLANT) COMPREHENSIVE SYSTEM (October 25, 2005)
  • K041382 — POLYGRAFT BGS; BONE GRAFT SUBSTITUTE (June 17, 2005)
  • K040047 — POLYGRAFT BGS; BONE GRAFT SUBSTITUTE (December 17, 2004)
  • K033707 — POLYGRAFT TCP GRANULES, CUBES, BLOCKS, PLUGS, WEDGES, MODELS 600-023-XX, 600-025 (August 16, 2004)
  • K032673 — IMMIX PLASTIFILM (October 2, 2003)
  • K030288 — POLYGRAFT BONE GRAFT SUBSTITUTE (July 17, 2003)
  • K024199 — IMMIX THIN FILM, MODELS: PSS-004-S, PSS-004-SP, PSS-004-M, PSS-004-MP, PSS-004-L (March 14, 2003)
  • K013429 — ACTAEON PROBE (January 11, 2002)

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