FDA 510(k) clearance · back to tracker

prodisc® C; prodisc® C SK; prodisc® C Nova; prodisc® C Vivo Instruments

Centinel Spine, LLC cleared K263159 on 2026-10-07, decision: substantially equivalent

K-number

K263159

Sponsor

Centinel Spine, LLC

Device

prodisc® C; prodisc® C SK; prodisc® C Nova; prodisc® C Vivo Instruments

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-10-07

Product code

QLQ

Advisory committee

Orthopedic

Medical specialty

Orthopedic

Regulation number

888.4515

Official FDA record

Open K263159on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

Use this as a predicate

Drop K263159 into Compass and start a substantial-equivalence draft.

Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.

Try the sandbox

Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.