Expedium Viper 196788120

by Depuy Spine, Inc. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number10705034182537 UDI-DI	Date24 Sep 2015Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Recalls

1 recall · FDA

- Terminated Z-1674-2015 FDA Class II initiated 21 Apr 2015
Device does not mate as intended.

Specification

GUDID

Trade Name: Expedium Viper
Generic Name: Bone-screw internal spinal fixation system rod
Model / Ref / Catalog: 196788120

Primary DI / UDI-DI: 10705034182537
510(k) Number: K090648
K111136
FDA Product Code: NKB, MNH, MNI, KWP, KWQ, OSH
GMDN Term: Bone-screw internal spinal fixation system rod

Device Class: Class II
Regulation Number: 888.3070, 888.3050, 888.3060
GUDID distribution status: In Commercial Distribution

Sterilization Method: Moist Heat or Steam Sterilization

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Class I
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N/A 698345078

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N/A 698345079

Class I

See all devices from Depuy Spine, Inc. →

Properties

Single Use
Implantable
Prescription Use
Lot / Batch Number

Other properties (10)

Sterile: No
Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No