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Integrate-C

FDA UDI

Class I (US FDA UDI)

by Happe Spine

Identity

Trade Name
INTEGRATE-C FDA UDI
Generic Name
Internal spinal fixation procedure kit, reusable FDA UDI
Device Name
Single End Trial - Small 15x12x9mm 7deg FDA UDI
Model / Reference
Trial-Small 15x12x9mm 7deg FDA UDI
Description
Single End Trial - Small 15x12x9mm 7deg FDA UDI

Identifiers

Catalog Number
T09S07 FDA UDI
Primary DI / UDI-DI
G2308H1FT09S070 FDA UDI
FDA Product Code
LYQ FDA UDI
GMDN Term
Internal spinal fixation procedure kit, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Internal spinal fixation procedure kit, reusable

Integrate-C by Happe Spine — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Internal spinal fixation procedure kit, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Happe Spine

Sources (1)

  • FDA UDI afd8310d-a7c3-4217-a163-ab175a5da578 35 fields · synced Jun 1, 2026