Home / 510(k) Clearances / K230774

510(k) K230774

PERLA® TL System; TEKTONA® HV US Bone Cement by Spineart — Product Code PML

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2023
Date Received
March 21, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bone Cement, Posterior Screw Augmentation
Device Class
Class II
Regulation Number
888.3027
Review Panel
OR
Submission Type

The device is intended to augment the fixation of screws in a posterior spinal system construct.

Other clearances by Spineart

  • K242933 — SPINEART Navigation Instrument System (June 18, 2025)
  • K242890 — SPINEART Navigation Instrument System (March 7, 2025)
  • K242589 — Scarlet® AL-T (October 23, 2024)
  • K241644 — SPINEART Navigation Instrument System (August 7, 2024)
  • K241321 — Juliet® Ti LL Lumbar Interbody Device (July 18, 2024)
  • K240699 — SCARLET® AC-Ti (May 10, 2024)
  • K231069 — PERLA® TL Posterior Thoraco-lumbar Fixation System (October 25, 2023)
  • K230583 — Tryptik Ti (March 22, 2023)
  • K213470 — PERLA® TL Posterior Osteosynthesis System (January 21, 2022)
  • K210472 — SPINEART Navigation Instrument System (March 19, 2021)

Other clearances for product code PML

  • K252885 — OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System (January 22, 2026)
  • K241034 — Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System (June 12, 2024)
  • K231809 — Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Moment (October 20, 2023)
  • K222789 — VADER® Pedicle System, G21 Cement (January 9, 2023)
  • K221926 — Invictus® Bone Cement, Invictus Spinal Fixation System (December 20, 2022)
  • K222256 — BonOs® Inject Bone Cement; NEO Pedicle Screw System™ (August 26, 2022)
  • K212489 — BonOs Inject Bone Cement; NEO Pedicle Screw System (October 28, 2021)
  • K200596 — G21 Cement, VADER® Pedicle System (October 13, 2020)
  • K201362 — CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone (August 19, 2020)
  • K192818 — Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal Syste (March 31, 2020)