Altus Spine Sochi OCT Spinal System— 510(k) K210887

Clearance details

Applicant

Altus Partners, LLC

Product code

Code NKG

Device class

Class 2

Regulation

21 CFR 888.3075

Advisory panel

Orthopedic

Date received

2021-03-25

Decision date

2021-08-20

Decision

Substantially Equivalent

Clearance type

Traditional

Location

West Chester, PA, 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

• K243419 — Altus Spine Navigation System2025-05-08
• K211027 — Altus Spine Pedicle Screw System2022-09-16
• K211837 — Altus Spine Interbody Standalone Fusion System2022-04-19
• K200922 — Altus Spine HA Pedicle Screw System2021-01-26
• K200322 — Altus Spine Pedicle Screw System2020-06-02

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 →