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Novel

FDA UDI

Class II (US FDA UDI)

by Alphatec Spine, Inc.

Identity

Trade Name
Novel FDA UDI
Generic Name
Metallic spinal interbody fusion cage FDA UDI
Device Name
Novel ACC, Ti 15X30 12mm Flat FDA UDI
Model / Reference
64503-012 FDA UDI
Description
Novel ACC, Ti 15X30 12mm Flat FDA UDI

Identifiers

Primary DI / UDI-DI
00844856012912 FDA UDI
510(k) Number
K050553 FDA UDI
FDA Product Code
MQP FDA UDI
GMDN Term
Metallic spinal interbody fusion cage 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

Dimensions & Sizes

Size
Length — 30 Millimeter FDA UDI
Height — 12 Millimeter FDA UDI
Width — 15 Millimeter FDA UDI

Novel by Alphatec Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K050553 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Alphatec Spine, Inc.

Sources (1)

  • FDA UDI 59a16e1c-6d06-4da1-b9bf-436446130816 37 fields · synced Jun 6, 2026