IdentiTi

FDA UDI

Class II (US FDA UDI)

by Alphatec Spine, Inc.

Identity

Trade Name: IdentiTi FDA UDI
Generic Name: Spinal implant trial FDA UDI
Device Name: CERVICAL INTERFIXATED TRIAL, 8 x 16 x 14 mm, 12° FDA UDI
Model / Reference: 135-10-08161412 FDA UDI
Description: CERVICAL INTERFIXATED TRIAL, 8 x 16 x 14 mm, 12° FDA UDI

Identifiers

Primary DI / UDI-DI: 00190376273822 FDA UDI
510(k) Number: K202812 FDA UDI
FDA Product Code: OVE FDA UDI
GMDN Term: Spinal implant trial 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

FDA UDI

Single Use

FDA UDI

Implantable

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: Depth — 14 Millimeter FDA UDI
Width — 16 Millimeter FDA UDI
Angle — 12 degree FDA UDI
Height — 8 Millimeter FDA UDI

Category: Spinal implant trial

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

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Yellowstone — Summit Spine · Class II

Cleared under the same submission

K202812 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 db17af94-5293-4b93-8cd6-e94b74c91031 36 fields · synced Jun 8, 2026