Ennovate Cervical Spinal and Occiput System— 510(k) K213871

Clearance details

Applicant

Aesculap Implant Systems, LLC

Product code

Code NKG

Device class

Class 2

Regulation

21 CFR 888.3075

Advisory panel

Orthopedic

Date received

2021-12-13

Decision date

2022-07-01

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Center Valley, 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

• K210963 — ENNOVATE Spinal System2021-07-19
• K180433 — ENNOVATE®2018-04-26
• K162134 — ENNOVATE Spinal System2016-12-14
• K153700 — Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments2016-07-08
• K153396 — Aesculap OrthoPilot Next Generation2016-05-16

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 →