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 8°, Ti 6Al 4V (ELI), HA FDA UDI
- Model / Reference
- 65-12141208 FDA UDI
- Description
- HAtetracell-C, 12L x 14W x 12H x 8°, Ti 6Al 4V (ELI), HA FDA UDI
Identifiers
- Primary DI / UDI-DI
- M71165121412080 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
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
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 12 Millimeter FDA UDIHeight — 12 Millimeter FDA UDIAngle — 8 degree FDA UDIWidth — 14 Millimeter FDA UDI
Category: Metallic spinal interbody fusion cage
HAtetracell™-C by Innovasis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Metallic spinal interbody fusion cage.
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- Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II
- MectaLIF 3D — Medacta International · Class II
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Cleared under the same submission
K231899 also covers:
- HAtetracell™-C — Innovasis, Inc.
- HAtetracell™-C — Innovasis, Inc.
- HAtetracell™-C — Innovasis, Inc.
- HAtetracell™-C — Innovasis, Inc.
- HAtetracell™-C — Innovasis, Inc.
- HAtetracell™-C — Innovasis, Inc.
- HAtetracell™-C — Innovasis, Inc.
- HAtetracell™-C — Innovasis, Inc.
- HAtetracell™-C — Innovasis, Inc.
- HAtetracell™-C — Innovasis, Inc.
- HAtetracell™-C — Innovasis, Inc.
- HAtetracell™-C — Innovasis, Inc.
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 9a2d8e9a-2011-456a-8d8c-2f20385e80f2 36 fields · synced May 30, 2026