Additional VIPER PRIME™ screws with fenestrations

by Medos International SARL 510(k)

Active United States

510(k) K171570

Regulatory status

as of 28 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Special	NumberK171570	Date31 Aug 2017Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 25 Oct 2026.

Specification

510(k)

510(k) Number: K171570
FDA Product Code: NKB

Device Class: Class II
Regulation: 21 CFR Part 888.3070
Advisory Committee: Orthopedic
FDA Decision: SESE Substantially Equivalent

Other devices from Medos International SARL

Expedium Spine System

Class III
Confidence Spinal Cement System

Class III
Viper System

Class III
Viper 2 System

Class IIb
Expedium Verse Spine System

Class IIb
SRT Modified Holder Screwdriver Inserter Sleeve Clamp Template Reducer

Class I

See all devices from Medos International SARL →