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510(k) K141282

PGS 5.5 MM CANNULATED PEDICLE SCREW by Pinnacle Spine Group — Product Code NKB

K141282 is an FDA 510(k) premarket notification submitted by Pinnacle Spine Group for the device "PGS 5.5 MM CANNULATED PEDICLE SCREW". The FDA issued a decision of Substantially Equivalent on Dec 2, 2014. The device falls under product code NKB (Thoracolumbosacral Pedicle Screw System), a Class II device regulated under 21 CFR 888.3070. Pinnacle Spine Group has 12 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Dec 2, 2014
Date Received
May 16, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thoracolumbosacral Pedicle Screw System
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type
510(k)

Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.

Other clearances by Pinnacle Spine Group

  • K172349 — InFill® Interbody Fusion Device (Dec 14, 2017)
  • K152259 — InFill Interbody Fusion Device (Nov 19, 2015)
  • K151184 — InFill Interbody Fusion Devices (Jul 14, 2015)
  • K150206 — InFill Interbody Fusion Devices (Apr 3, 2015)
  • K143488 — InFill Graft Delivery System (Dec 17, 2014)
  • K140066 — INFILL CERVICAL (May 5, 2014)
  • K133721 — INFILL 41-TLIF CONVEX OBLIQUE DEVICE, INFILL 43-TLIF CONTOUR OBLIQUE, INFILL… (Mar 31, 2014)
  • K124012 — INFILL OBLIQUE TLIF DEVICE (Jun 4, 2013)
  • K121476 — INFILL GRAFT DELIVERY SYSTEM (Aug 29, 2012)
  • K121733 — INFILL INTERVERTEBRAL BODY FUSION DEVICE (Jul 13, 2012)

Other clearances for product code NKB

  • K262091 — FRAXION Spinal Fixation System (Sep 17, 2026)
  • K262193 — RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor… (Sep 14, 2026)
  • K262828 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (Sep 4, 2026)
  • K253943 — Tiger 2 System (Jul 24, 2026)
  • K260362 — QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS… (Jul 24, 2026)
  • K261284 — Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation… (Jul 14, 2026)
  • K253802 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (Jul 1, 2026)
  • K253045 — “Socko” Vimax Spinal Fixation System (Jun 17, 2026)
  • K251251 — ChanPin Pedicle Screw Spinal System (Jun 9, 2026)
  • K260989 — Varion Thoracolumbar Fixation System (May 15, 2026)

FDA data resources