← Back to catalogue

Novel

FDA UDI

Class II (US FDA UDI)

by Alphatec Spine, Inc.

Identity

Trade Name
Novel FDA UDI
Generic Name
Polymeric spinal interbody fusion cage FDA UDI
Device Name
SPINAL SPACER, LARGE, TAPERED, LORDOTIC, 13MM, NOVEL, TL FDA UDI
Model / Reference
64659-113 FDA UDI
Description
SPINAL SPACER, LARGE, TAPERED, LORDOTIC, 13MM, NOVEL, TL FDA UDI

Identifiers

Primary DI / UDI-DI
00844856014855 FDA UDI
510(k) Number
K080699 FDA UDI
FDA Product Code
MAX FDA UDI
MQP FDA UDI
GMDN Term
Polymeric spinal interbody fusion cage FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3080 FDA UDI
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

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

Cleared under the same submission

K080699 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Alphatec Spine, Inc.

Sources (1)

  • FDA UDI 01d7a9d6-496e-4582-98c9-6fe0528b4c45 36 fields · synced Jun 8, 2026