ACCELL EVO3C— 510(k) K091193

Substantially Equivalent

Isotis Orthobiologics, Inc.

FDA 510(k) clearance K091193 for ACCELL EVO3C, Substantially Equivalent on 2009-08-10. Applicant: Isotis Orthobiologics, Inc.. Device class: 2.

Clearance details

Applicant: Isotis Orthobiologics, Inc.
Product code: Code MBP
Device class: Class 2
Regulation: 21 CFR 888.3045
Advisory panel: Orthopedic
Date received: 2009-04-23
Decision date: 2009-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Isotis Orthobiologics, Inc.

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K050642 — ORTHOBLAST II PUTTY AND PASTE2005-12-05
K052098 — CONNEXUS, .5CC, MODEL 023000-0052005-09-07
K043573 — DYNAGRAFT II DENTAL2005-07-29

Recalls naming K091193

K-number listed on FDA's recall record

Z-1868-2014 — Accell Evo3C Demineralized Bone Matrix, 5 cc, Model Number: 02-6000-050 , Lot Number: 132160. Product Usage: Accell Evo3c Demineralized Bone Matrix Putty is intended for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. Accell Evo3c is indicated for use as a bone graft extender in the spine, extremities and pelvis, or as a bone void filler in the extremities and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone.Class II·Terminated·Integra LifeSciences Corp.·20140519

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K091193.

Data sourced from openFDA. This site is unofficial and independent of the FDA.