Product code OMR— Cardiovascular

“These device types do not include devices whose primary purpose is to minimize the incidence or severity of adhesion formation as a result of vascular surgery. Intended to protect vessels from injury during surgery (not to be confused with wraps, patches or covers intended to facilitate revision surgeries). Indicated to wrap, patch, or cover intended to cover blood vessels.”

FDA has cleared 10 devices under product code OMR between 2009 and 2012, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20121 clearance
• 20113 clearances
• 20103 clearances
• 20093 clearances

• Mimedx Group, Inc.4 clearances
• Synthes Spine2 clearances
• Spinemedica, LLC2 clearances
• Xylos Corporation1 clearance
• Replication Medical, Inc.1 clearance

• K111048 — SYNTHES SCOUT TACK FIXATIONSynthes Spine·2012-06-14
• K111137 — HYDROFIX VASO SHIELDMimedx Group, Inc.·2011-05-20
• K101805 — HYDROFIX VASO SHIELDMimedx Group, Inc.·2011-04-08
• K103558 — SYNTHES SCOUT VESSEL GUARDSynthes Spine·2011-02-18
• K101826 — HYDROFIX VASO SHIELD, MODEL HVS-001-0610Mimedx Group, Inc.·2010-07-28
• K100984 — XYLOS VESSEL GUARDXylos Corporation·2010-07-07
• K100905 — HYDROFIX SURGICAL SHEETMimedx Group, Inc.·2010-06-02
• K093551 — PARADIS VASO SHIELDSpinemedica, LLC·2009-12-24
• K090022 — PARADIS VASO SHIELDSpinemedica, LLC·2009-04-20
• K082782 — REPLICATION MEDICAL VESSEL GUARDReplication Medical, Inc.·2009-04-02