When did Virata Spinal Fixation System receive FDA clearance or approval?

Virata Spinal Fixation System (Submission ID: K262731) was fda cleared by the U.S. FDA on 2026-10-29 under the 510K pathway with a review duration of 90 days.

Who is the manufacturer or applicant for Virata Spinal Fixation System?

The applicant and sponsor for K262731 is SeaSpine Orthopedics Corporation.

Is K262731 an AI/ML-enabled medical device?

No. This medical device submission is not designated as incorporating AI/ML software algorithms.

FDA Cleared New Device Pathway: 510K

Virata Spinal Fixation System

Applicant: SeaSpine Orthopedics Corporation

Statutory Profile

Legal Standard:

Substantial Equivalence (SE) to predicate (21 CFR 807)

Product Code:

NKB

Review Panel:

Orthopedic

21 CFR Regulation:

Review Velocity Metrics

Date Received:

2026-07-31

Decision Date:

2026-10-29

Total Review Duration:

90 calendar days (90 days)

Official FDA Research Backlinks

Direct links to primary official records hosted by the U.S. Food and Drug Administration CDRH databases:

FDA Database Webpage (pmn.cfm) Official Decision Summary PDF Product Classification Database Establishment Registration & Listing

Identified Contacts & Correspondents

Sali Gully

Role: SUBMITTER_CONTACT

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