HAtetracell™-C

FDA UDI

Class II (US FDA UDI)

by Innovasis, Inc.

Identity

Trade Name: HAtetracell™-C FDA UDI
Generic Name: Metallic spinal interbody fusion cage FDA UDI
Device Name: HAtetracell-C, 12L x 14W x 12H x 12°, Ti 6Al 4V (ELI), HA FDA UDI
Model / Reference: 65-12141212 FDA UDI
Description: HAtetracell-C, 12L x 14W x 12H x 12°, Ti 6Al 4V (ELI), HA FDA UDI

Identifiers

Primary DI / UDI-DI: M71165121412120 FDA UDI
510(k) Number: K231899 FDA UDI
FDA Product Code: ODP FDA UDI
GMDN Term: Metallic spinal interbody fusion cage 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

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

Dimensions & Sizes

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

Category: Metallic spinal interbody fusion cage

The HAtetracell-C is a cutting-edge, patented metallic spinal interbody fusion cage designed to provide a stable and conducive environment for bone fusion between two contiguous vertebral bodies. This innovative device has been developed in collaboration with top orthopedic surgeons to address the growing need for effective treatment of degenerative disc disease.

Similar devices

Also classified as Metallic spinal interbody fusion cage.

KODIAK CERVICAL IMPLANT, 14x16mm, 10mmx6° — MET 1 TECHNOLOGIES, LLC · Class II
Peridot-PT Anterior Cervical Intervertebral body fusion system — GBS Commonwealth Co., Ltd. · Class II
CoRoent — Nuvasive, Inc. · Class II
Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II
MectaLIF 3D — Medacta International · Class II
PILLAR TL — Orthofix US LLC · Class II
Solar™ Interbody Fusion System — Degen Medical · Class II
Peridot-TD Anterior Cervical Intervertebral body fusion system — GBS Commonwealth Co., Ltd. · Class II

Cleared under the same submission

K231899 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: Innovasis, Inc.

Sources (1)

FDA UDI 6565f71c-2876-4ace-9927-4d1a1d5635d9 36 fields · synced Jul 31, 2026