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510(k) K122931

S-LOK PSS SYSTEM by Spinal USA — Product Code MNI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 2012
Date Received
September 24, 2012
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

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  • K103369 — VAULT ALIF SYSTEM (April 4, 2011)
  • K092659 — SPINAL USA RCS ANTERIOR LUMBAR BUTRESS PLATE SYSTEM, MODEL 22-1001-25 (November 17, 2009)

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  • K152324 — YAHUA Spinal System (February 1, 2016)
  • K143222 — FIREFLY Pedicle Screw Navigation Guide (December 11, 2015)
  • K150684 — WASTON General Spinal System (November 18, 2015)