Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TiLock2 Spinal System

K-Number: K171838 · 2017-07-19

ApplicantGenesys Spine
Decision Date2017-07-19
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TiLock2 Spinal System is a medical device manufactured by Genesys Spine. It received FDA 510(k) clearance on 2017-07-19 under approval number K171838. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TiLock2 Spinal System?

TiLock2 Spinal System is a medical device that received FDA 510(k) clearance on 2017-07-19. It is manufactured by Genesys Spine. The 510(k) number is K171838.

When was TiLock2 Spinal System approved by the FDA?

TiLock2 Spinal System received FDA 510(k) clearance on 2017-07-19, under approval number K171838.

What company makes TiLock2 Spinal System?

TiLock2 Spinal System is manufactured by Genesys Spine.

What is the FDA product code for TiLock2 Spinal System?

The FDA product code for TiLock2 Spinal System is NKB.

Related Clinical Trials

Related PubMed Literature

Other Devices by Genesys Spine

View all 21 devices →

Related Devices (Code: NKB)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.