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510(k) K113149

SYNTHES USS CONNECTORS by Synthes Spine — Product Code MNI

K113149 is an FDA 510(k) premarket notification submitted by Synthes Spine for the device "SYNTHES USS CONNECTORS". The FDA issued a decision of Substantially Equivalent on February 1, 2012. The device falls under product code MNI (Orthosis, Spinal Pedicle Fixation), a Class II device regulated under 21 CFR 888.3070. Synthes Spine has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 2012
Date Received
October 24, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Spinal Pedicle Fixation
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

Other clearances by Synthes Spine

  • K122211 — SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTS (December 17, 2012)
  • K120838 — SYNTHES MATRIX SYSTEM (July 31, 2012)
  • K111048 — SYNTHES SCOUT TACK FIXATION (June 14, 2012)
  • K120928 — SYNTHES MATRIX SYSTEM (May 18, 2012)
  • K120571 — SYNTHES USS CONNECTOR (May 14, 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 MNI

  • K171497 — Mikron Spinal Fixation System (October 12, 2017)
  • K160731 — LumFix Spinal Fixation Sytem (October 4, 2016)
  • K151458 — Double Medical Universal Spine System (August 22, 2016)
  • K153273 — MySpine Pedicle Screw Placement Guides - LP (June 29, 2016)
  • K160124 — LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation (April 4, 2016)
  • K160320 — Premier (April 1, 2016)
  • K160003 — Sniper (R) Spine System (February 26, 2016)
  • K152324 — YAHUA Spinal System (February 1, 2016)
  • K143222 — FIREFLY Pedicle Screw Navigation Guide (December 11, 2015)
  • K150684 — WASTON General Spinal System (November 18, 2015)

FDA data resources