Identity
- Trade Name
- INTEGRATE-C FDA UDI
- Generic Name
- Internal spinal fixation procedure kit, reusable FDA UDI
- Device Name
- Rasping Trial - Large footprint 7deg, 9/10 height FDA UDI
- Model / Reference
- Rasping Trial - Large 20 x 15 x 9/10 mm, 7 deg FDA UDI
- Description
- Rasping Trial - Large footprint 7deg, 9/10 height FDA UDI
Identifiers
- Catalog Number
- R0910L07 FDA UDI
- Primary DI / UDI-DI
- G2308H1CR090L70 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
MR Conditional 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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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 78070eb0-ae98-43d9-92e3-8fafc19fc2eb 36 fields · synced Jun 8, 2026