Identity
- Trade Name
- INTEGRATE-C FDA UDI
- Generic Name
- Internal spinal fixation procedure kit, reusable FDA UDI
- Device Name
- Inserter Handle FDA UDI
- Model / Reference
- Inserter Handle FDA UDI
- Description
- Inserter Handle FDA UDI
Identifiers
- Catalog Number
- H00000031 FDA UDI
- Primary DI / UDI-DI
- G2308H1CH000310 FDA UDI
- 510(k) Number
- K222004 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
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
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Also classified as Internal spinal fixation procedure kit, reusable.
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- Zavation — ZAVATION · Class II
- 4CIS® INSTRUMENT SYSTEM — ALPHANOX CO., LTD. · Class I
- ReLine — Nuvasive, Inc. · Class I
- VuePoint — Nuvasive, Inc. · Class I
Cleared under the same submission
K222004 also covers:
- INTEGRATE-C — Happe Spine
- INTEGRATE-C — Happe Spine
- INTEGRATE-C — Happe Spine
- INTEGRATE-C — Happe Spine
- INTEGRATE-C — Happe Spine
- INTEGRATE-C — Happe Spine
- INTEGRATE-C — Happe Spine
- INTEGRATE-C — Happe Spine
- INTEGRATE-C — Happe Spine
- INTEGRATE-C — Happe Spine
- INTEGRATE-C — Happe Spine
- INTEGRATE-C — Happe Spine
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Happe Spine
Sources (1)
- FDA UDI 14f04d68-00be-4247-bc3f-ef4517028b0a 36 fields · synced Jun 1, 2026