PERLA® Posterior Occipito-Cervico-Thoracic Fixation System— 510(k) K200571

Clearance details

Applicant

Spineart

Product code

Code NKG

Device class

Class 2

Regulation

21 CFR 888.3075

Advisory panel

Orthopedic

Date received

2020-03-04

Decision date

2020-05-01

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Plan Les Ouates, CH

• K253195 — TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems2026-06-02
• K254045 — CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System2026-03-16
• K254165 — Infinity OCT System2026-01-21
• K252327 — CMORE® CT System; CMORE® CT System Navigated Instruments2025-11-12
• K253129 — Infinity OCT System2025-10-24

• K230774 — PERLA® TL System; TEKTONA® HV US Bone Cement2023-06-23
• 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

Death

15

Injury

1,090

Malfunction

529

Total

1,634

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 →