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510(k) K090033

MODIFICATION TO: PSS SYSTEM by Spinal USA — Product Code MNI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 2009
Date Received
January 6, 2009
Clearance Type
Special
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 Spinal USA

  • K132029 — VAULT-C INTERVERTEBRAL BODY FUSION DEVICE (November 25, 2013)
  • K130863 — FACET SCREW SYSTEM (August 9, 2013)
  • K131343 — REFORM PEDICLE SCREW SYSTEM (July 24, 2013)
  • K130279 — REFORM PEDICLE SCREW SYSTEM (June 20, 2013)
  • K130445 — VAULT ALIF SYSTEM (April 25, 2013)
  • K122931 — S-LOK PSS SYSTEM (November 20, 2012)
  • K121172 — REFORM PEDICLE SCREW SYSTEM (August 8, 2012)
  • K112748 — SLIMPLICITY SOLO ANTERIOR CERVICAL PLATE SYSTEM (July 11, 2012)
  • K112025 — SURE LOK MINI POSTERIOR CERVICAL/UPPER THORACIC SYSTEM (September 15, 2011)
  • K103369 — VAULT ALIF SYSTEM (April 4, 2011)

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)