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510(k) K112025

SURE LOK MINI POSTERIOR CERVICAL/UPPER THORACIC SYSTEM by Spinal USA — Product Code KWP

K112025 is an FDA 510(k) premarket notification submitted by Spinal USA for the device "SURE LOK MINI POSTERIOR CERVICAL/UPPER THORACIC SYSTEM". The FDA issued a decision of Substantially Equivalent on September 15, 2011. The device falls under product code KWP (Appliance, Fixation, Spinal Interlaminal), a Class II device regulated under 21 CFR 888.3050. Spinal USA has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2011
Date Received
July 15, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Interlaminal
Device Class
Class II
Regulation Number
888.3050
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)
  • K103369 — VAULT ALIF SYSTEM (April 4, 2011)
  • K092659 — SPINAL USA RCS ANTERIOR LUMBAR BUTRESS PLATE SYSTEM, MODEL 22-1001-25 (November 17, 2009)

Other clearances for product code KWP

  • K143278 — LnK Posterior Cervical Fixation System (July 29, 2015)
  • K150753 — OASYS System (June 9, 2015)
  • K150851 — Sure Lok Mini Posterior Cervical/Upper Thoracic System (June 4, 2015)
  • K142867 — Reliance Posterior Cervical-Thoracic System (April 29, 2015)
  • K150254 — Streamline OCT Occipito-Cervico-Thoracic System (April 28, 2015)
  • K142253 — SOLSTICE OCT System (April 23, 2015)
  • K150229 — SOLSTICE OCT System (April 7, 2015)
  • K143249 — SOLSTICE OCT System (April 7, 2015)
  • K142741 — OASYS System (January 15, 2015)
  • K142558 — Caspian OCT/MESA Mini/DENALI Mini Spinal System (December 22, 2014)

FDA data resources