510(k) K051656

OCT (OSTEOCHONDRAL TRANSPLANT) COMPREHENSIVE SYSTEM by Osteobiologics, Inc. — Product Code HRX

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 25, 2005
Date Received: June 21, 2005
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Arthroscope
Device Class: Class II
Regulation Number: 888.1100
Review Panel: OR
Submission Type

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Osteobiologics, Inc.

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)
K013429 — ACTAEON PROBE (January 11, 2002)

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K252666 — Articulator Arthroscopic Bur (November 21, 2025)
K252458 — Kyphoplasty Balloon Dilatation Catheters (November 3, 2025)
K252020 — TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly (October 15, 2025)
K252594 — UltraGuideCTR® image guided soft tissue release system (September 29, 2025)
K243774 — ELID (Endoscopic Less Invasive Decompression) System (August 27, 2025)
K241990 — SpineSite Endoscope System (July 30, 2025)
K243602 — Arthrex Spine Endoscope (May 16, 2025)