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510(k) K013429

ACTAEON PROBE by Osteobiologics, Inc. — Product Code NGR

K013429 is an FDA 510(k) premarket notification submitted by Osteobiologics, Inc. for the device "ACTAEON PROBE". The FDA issued a decision of Substantially Equivalent on January 11, 2002. The device falls under product code NGR (Tester, Stiffness, Cartilage, Arthroscopic), a Class II device regulated under 21 CFR 888.1100. Osteobiologics, Inc. has at least 8 other 510(k) clearances on record.

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

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)
  • 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)

FDA data resources