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Keystone ALIF System

FDA UDI

Class I (US FDA UDI)

by Evolution Spine, Llc

Identity

Trade Name
Keystone ALIF System FDA UDI
Generic Name
Orthopaedic osteotome FDA UDI
Device Name
Osteotome 12mm x 25mm Straight Short handle FDA UDI
Model / Reference
DP-003 FDA UDI
Description
Osteotome 12mm x 25mm Straight Short handle FDA UDI

Identifiers

Catalog Number
DP-003 FDA UDI
Primary DI / UDI-DI
00195860015285 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Orthopaedic osteotome FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic osteotome

Keystone ALIF System by Evolution Spine, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic osteotome.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Evolution Spine, Llc

Sources (1)

  • FDA UDI b34c419d-3b81-44ac-b593-34dbc1b9a94d 35 fields · synced May 30, 2026