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510(k) K201751

Pedicle Screw System by Black Box Medical, LLC — Product Code NKB

K201751 is an FDA 510(k) premarket notification submitted by Black Box Medical, LLC for the device "Pedicle Screw System". The FDA issued a decision of Substantially Equivalent on Jul 22, 2020. The device falls under product code NKB (Thoracolumbosacral Pedicle Screw System), a Class II device regulated under 21 CFR 888.3070. Black Box Medical, LLC has 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jul 22, 2020
Date Received
Jun 26, 2020
Clearance Type
Special
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 Black Box Medical, LLC

  • K182283 — FUSE Pedicle Screw System (Oct 23, 2018)
  • K181554 — Stowe Pedicle Screw System (Jul 27, 2018)

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