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ALTIVO Anterior Cervical Fixation System

FDA UDI

Class II (US FDA UDI)

by Camber Spine Technologies

Identity

Trade Name
ALTIVO Anterior Cervical Fixation System FDA UDI
Generic Name
Spinal fixation plate, non-bioabsorbable FDA UDI
Device Name
1-1, 35mm plate, extended FDA UDI
Model / Reference
FCP-2335E FDA UDI
Description
1-1, 35mm plate, extended FDA UDI

Identifiers

Primary DI / UDI-DI
B030FCP2335E0 FDA UDI
510(k) Number
K191584 FDA UDI
FDA Product Code
KWQ FDA UDI
GMDN Term
Spinal fixation plate, non-bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3060 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

No

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

ALTIVO Anterior Cervical Fixation System by Camber Spine Technologies — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K191584 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Camber Spine Technologies

Sources (1)

  • FDA UDI b1f9b8f3-0b0d-4b76-81a7-aa3ef3c5c839 36 fields · synced Jun 1, 2026