PERLA® TL System; TEKTONA® HV US Bone Cement— 510(k) K230774

Clearance details

Applicant

Spineart

Product code

Code PML

Device class

Class 2

Regulation

21 CFR 888.3027

Advisory panel

Orthopedic

Date received

2023-03-21

Decision date

2023-06-23

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Geneva, CH

• K260286 — Dynamo Spinal Cement; Salvo® Spine System2026-06-15
• K252885 — OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System2026-01-22
• K241034 — Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System2024-06-12
• K231809 — Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement +1 more2023-10-20
• K222789 — VADER® Pedicle System, G21 Cement2023-01-09

• K213470 — PERLA® TL Posterior Osteosynthesis System2022-01-21
• K210472 — SPINEART Navigation Instrument System2021-03-19
• K203506 — PERLA® TL posterior osteosynthesis system2021-01-15
• K203222 — PERLA TL Posterior Osteosynthesis System2020-12-17
• K200571 — PERLA® Posterior Occipito-Cervico-Thoracic Fixation System2020-05-01

Death

8

Total

8

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →