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510(k) K111048

SYNTHES SCOUT TACK FIXATION by Synthes Spine — Product Code OMR

K111048 is an FDA 510(k) premarket notification submitted by Synthes Spine for the device "SYNTHES SCOUT TACK FIXATION". The FDA issued a decision of SESU on June 14, 2012. The device falls under product code OMR (Vessel Guard Or Cover), a Class II device regulated under 21 CFR 870.3470. Synthes Spine has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESU ()
Decision Date
June 14, 2012
Date Received
April 15, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Vessel Guard Or Cover
Device Class
Class II
Regulation Number
870.3470
Review Panel
CV
Submission Type

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.

Other clearances by Synthes Spine

  • K122211 — SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTS (December 17, 2012)
  • K120838 — SYNTHES MATRIX SYSTEM (July 31, 2012)
  • K120928 — SYNTHES MATRIX SYSTEM (May 18, 2012)
  • K120571 — SYNTHES USS CONNECTOR (May 14, 2012)
  • K113149 — SYNTHES USS CONNECTORS (February 1, 2012)
  • K113044 — SYNTHES MIRS (December 21, 2011)
  • K111358 — SYNTHES USS (November 18, 2011)
  • K103558 — SYNTHES SCOUT VESSEL GUARD (February 18, 2011)
  • K103287 — SYNTHES 6.0 COCR AND CPT TI-3 RODS (January 5, 2011)
  • K093762 — SYNTHES ZERO-P (December 20, 2010)

Other clearances for product code OMR

  • K111137 — HYDROFIX VASO SHIELD (May 20, 2011)
  • K101805 — HYDROFIX VASO SHIELD (April 8, 2011)
  • K103558 — SYNTHES SCOUT VESSEL GUARD (February 18, 2011)
  • K101826 — HYDROFIX VASO SHIELD, MODEL HVS-001-0610 (July 28, 2010)
  • K100984 — XYLOS VESSEL GUARD (July 7, 2010)
  • K100905 — HYDROFIX SURGICAL SHEET (June 2, 2010)
  • K093551 — PARADIS VASO SHIELD (December 24, 2009)
  • K090022 — PARADIS VASO SHIELD (April 20, 2009)
  • K082782 — REPLICATION MEDICAL VESSEL GUARD (April 2, 2009)

FDA data resources