Infinity OCT System— 510(k) K253129
Substantially EquivalentMedtronic Sofamor Danek USA, Inc.
FDA 510(k) clearance K253129 for Infinity OCT System, Substantially Equivalent on 2025-10-24. Applicant: Medtronic Sofamor Danek USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- Product code
- Code NKG
- Device class
- Class 2
- Regulation
- 21 CFR 888.3075
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Memphis, TN, US
Recent devices under product code NKG
view all- K253195 — TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems
- K254045 — CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System
- K254165 — Infinity OCT System
- K252327 — CMORE® CT System; CMORE® CT System Navigated Instruments
- K251725 — ANAX OCT Spinal System
More clearances from Medtronic Sofamor Danek USA, Inc.
view all- K253011 — Catalyft PL Expandable Interbody System
- K261020 — Symmetrix L Spinal System
- K253656 — OsteoCool RF Ablation System; OsteoCool 2.0 RF Ablation System
- K260216 — CD Horizon ModuLeX Fenestrated Screw Set; CD Horizon ModuLeX Spinal System
- K253941 — CD Horizon ModuLeX Spinal System (LigaMAS Head Assembly)
Adverse events under product code NKG
product code NKG- Death
- 15
- Injury
- 1,090
- Malfunction
- 529
- Total
- 1,634
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.