510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K230774Substantially Equivalent

PERLA® TL System; TEKTONA® HV US Bone Cement

Spineart SA, Geneva, CH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K230774 is the FDA 510(k) clearance record for PERLA® TL System; TEKTONA® HV US Bone Cement, a class II device, cleared for Spineart on under FDA product code PML (Bone Cement, Posterior Screw Augmentation). FDA's definition for product code PML reads: "The device is intended to augment the fixation of screws in a posterior spinal system construct". FDA records list 57 510(k) clearances for Spineart, from to . As of , FDA records show no recalls naming K230774.

Clearance record

Decision date
Received
(94 days to decision)
Product code
PML Bone Cement, Posterior Screw Augmentation
Regulation
21 CFR 888.3027
Device class
Class II
Review panel
Orthopedic
Applicant
Spineart 3 Chemin De Pré Fleuri, Geneva, CH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PML

Trailing 12 months
2 clearances under product code PML in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PML, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260