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Addivation Medical Cervical Interbody Device

FDA UDI

Class II (US FDA UDI)

by Addivation Medical, Llc

Identity

Trade Name
Addivation Medical Cervical Interbody Device FDA UDI
Generic Name
Spinal fusion sphere FDA UDI
Device Name
Cervical Spine Interbody Device. 14 x 16mm footprint, 6mm height, 6 degrees lordosis. FDA UDI
Model / Reference
AOCS6146 FDA UDI
Description
Cervical Spine Interbody Device. 14 x 16mm footprint, 6mm height, 6 degrees lordosis. FDA UDI

Identifiers

Primary DI / UDI-DI
B804AOCS61461 FDA UDI
510(k) Number
K190291 FDA UDI
FDA Product Code
ODP FDA UDI
GMDN Term
Spinal fusion sphere FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3080 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Spinal fusion sphere

Addivation Medical Cervical Interbody Device by Addivation Medical, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spinal fusion sphere.

Cleared under the same submission

K190291 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Addivation Medical, Llc

Sources (1)

  • FDA UDI c45f7992-8c7b-4177-ac93-a114b25a27d8 34 fields · synced May 30, 2026