Cleared Traditional

PERLA? TL System; TEKTONA? HV US Bone Cement

K230774 · Spineart · Orthopedic

Jun 2023

Decision

94d

Days

Class 2

Risk

About This 510(k) Submission

K230774 is an FDA 510(k) clearance for the PERLA? TL System; TEKTONA? HV US Bone Cement, a Bone Cement, Posterior Screw Augmentation (Class II — Special Controls, product code PML), submitted by Spineart (Geneva, CH). The FDA issued a Cleared decision on June 23, 2023, 94 days after receiving the submission on March 21, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number	K230774 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 21, 2023
Decision Date	June 23, 2023
Days to Decision	94 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	PML — Bone Cement, Posterior Screw Augmentation
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3027
Definition	The Device Is Intended To Augment The Fixation Of Screws In A Posterior Spinal System Construct.