Posterior Cervical Spine System— 510(k) K233078

Clearance details

Applicant

Double Medical Technology, Inc.

Product code

Code NKG

Device class

Class 2

Regulation

21 CFR 888.3075

Advisory panel

Orthopedic

Date received

2023-09-25

Decision date

2023-11-22

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Xiamen, CN

• 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

• K252729 — Universal Spinal System2025-11-18
• K242348 — Locking Screw,CoCrMo2024-12-04
• K223753 — Cervical Plate System2023-03-14
• K221150 — Advanced Bone Plate2023-01-25
• K221088 — Anatomic Bone Plate2023-01-18

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 →