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510(k) K013429

ACTAEON PROBE by Osteobiologics, Inc. — Product Code NGR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 2002
Date Received
October 16, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tester, Stiffness, Cartilage, Arthroscopic
Device Class
Class II
Regulation Number
888.1100
Review Panel
OR
Submission Type

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  • 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)

Other clearances for product code NGR

  • K010303 — ARTSCAN CARTILAGE STIFFNESS TESTING DEVICE (September 11, 2001)