NorthStar OCT System— 510(k) K231654
Substantially EquivalentSeaspine, Inc.
FDA 510(k) clearance K231654 for NorthStar OCT System, Substantially Equivalent on 2023-08-03. Applicant: Seaspine, Inc.. Device class: 2.
Clearance details
- Applicant
- Seaspine, 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
- Traditional
- Location
- Carlsbad, CA, US
Recent devices under product code NKG
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view all- K150469 — Integra Laminoplasty System
- K142488 — SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria NanoMetalene , Vu aPOD-L NanoMetalene, Vu ePOD NanoMetalene
- K133418 — INTEGRA EXPANDABLE INTERVEREBRAL BODY FUSION DEVICE (IBD) SYSTEM
- K132859 — INTEGRA FACET FIXATION SYSTEM
- K121924 — INTEGRA INTERSPINOUS PROCESS SYSTEM
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.