Novel

FDA UDI

Class II (US FDA UDI)

by Alphatec Spine, Inc.

Identity

Trade Name: Novel FDA UDI
Generic Name: Vertebral body prosthesis FDA UDI
Device Name: CP - PEEK 5 DEGREES SMALL SPACER - 14MMX12MMX19MM FDA UDI
Model / Reference: 64713-119 FDA UDI
Description: CP - PEEK 5 DEGREES SMALL SPACER - 14MMX12MMX19MM FDA UDI

Identifiers

Primary DI / UDI-DI: 00844856015814 FDA UDI
510(k) Number: K050553 FDA UDI
FDA Product Code: MQP FDA UDI
GMDN Term: Vertebral body prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3060 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Length — 14 Millimeter FDA UDI
Width — 12 Millimeter FDA UDI
Angle — 5 degree FDA UDI
Height — 19 Millimeter FDA UDI

Category: Vertebral body prosthesis

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

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Also classified as Vertebral body prosthesis.

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Cleared under the same submission

K050553 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Alphatec Spine, Inc.

Sources (1)

FDA UDI 39cc6e0c-0ea8-480b-bea9-e9bd60b1b6bf 36 fields · synced Jun 8, 2026