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510(k) K024199

IMMIX THIN FILM, MODELS: PSS-004-S, PSS-004-SP, PSS-004-M, PSS-004-MP, PSS-004-L, PSS-004-LP by Osteobiologics, Inc. — Product Code FTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2003
Date Received
December 20, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Polymeric
Device Class
Class II
Regulation Number
878.3300
Review Panel
SU
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)
  • K043172 — TRUGRAFT BGS SYRINGE, MODEL 600-041 (January 7, 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)
  • K013429 — ACTAEON PROBE (January 11, 2002)

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