Mega Plus Spine System 10160-10

by Bk Meditech Co., Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number08809763501265 UDI-DI	Date14 Jun 2023Listed	StatusListed GUDID: in commercial distribution

Official records

AccessGUDID record UDI-DI 08809763501265

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name: Mega Plus Spine System
Generic name: Surgical screwdriver, reusable
Model / reference: 10160-10

Primary DI / UDI-DI: 08809763501265
FDA product code: HXX
GMDN term: Surgical screwdriver, reusable

Device class: Class I
Regulation number: 888.4540
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

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Properties

Sterilise before use
Prescription use
Premarket exempt
Lot / batch number

Other properties (11)

Supplied sterile: No
Single use: No
Implantable: No
Contains latex: No
Over-the-counter: No
Convenience kit: No
Combination product: No
HCT/P: No
Serial number: No
Expiration date: No
Manufacturing date: No