BRIDALVEIL Occipital Cervical Thoracic System— 510(k) K171250

Clearance details

Applicant

Astura Medical

Product code

Code NKG

Device class

Class 2

Regulation

21 CFR 888.3075

Advisory panel

Orthopedic

Date received

2017-04-28

Decision date

2017-10-02

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Carlsbad, CA, US

• 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

• K252885 — OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System2026-01-22
• K252346 — OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System2025-10-21
• K243259 — MASADA Modular Spinal Fixation System2025-01-07
• K240160 — EGPS Navigated Instruments2024-10-17
• K233359 — DOMINION Expandable Corpectomy System2024-03-08

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 →