Integrate-C

FDA UDI

Class II (US FDA UDI)

by Happe Spine

Identity

Trade Name: INTEGRATE-C FDA UDI
Generic Name: Polymeric spinal interbody fusion cage FDA UDI
Device Name: HAPPE Spine - ACDF INTEGRATE-C Large, 20 x 15 x 10 mm ,7 deg FDA UDI
Model / Reference: Large, 20 x 15 x 10 mm ,7 deg FDA UDI
Description: HAPPE Spine - ACDF INTEGRATE-C Large, 20 x 15 x 10 mm ,7 deg FDA UDI

Identifiers

Catalog Number: 10L07 FDA UDI
Primary DI / UDI-DI: G2308H2AF10L070 FDA UDI
510(k) Number: K222004 FDA UDI
FDA Product Code: ODP FDA UDI
GMDN Term: Polymeric 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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Polymeric spinal interbody fusion cage

The INTEGRATE-C is a high-quality, polymeric spinal interbody fusion cage designed for the treatment of degenerative disc disease. This device features a large 20 x 15 x 10 mm size, with 7-degree angulation, and is intended to provide mechanical stability while facilitating bone fusion between two contiguous vertebral bodies. The INTEGRATE-C is a single-use implantable device that is exempt from direct marking for sale or use in the United States.

Similar devices

Also classified as Polymeric spinal interbody fusion cage.

L-Box® — Innovasis, Inc. · Class II
CoRoent — Nuvasive, Inc. · Class II
Novel Spinal Spacer System — ALPHATEC SPINE, INC. · Class II
S-LIFT® — SPINEFRONTIER, INC. · Class II
Peridot Intervertebral body fusion system — GBS Commonwealth Co., Ltd. · Class II
TAURUS PEEK Cage System — Medyssey Co., Ltd. · Class II
Cross-Fuse® II PEEK IBF System — Rti Surgical, Inc. · Class II
Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II

Cleared under the same submission

K222004 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: Happe Spine

Sources (1)

FDA UDI 68a1e6c2-03ef-4bbd-8251-ee09d9f15416 36 fields · synced Jun 27, 2026