Identity
- Trade Name
- HAtetracell™-C FDA UDI
- Generic Name
- Spinal implant trial FDA UDI
- Device Name
- Trial, 16L x 18W x 11-12H x 12°, SST FDA UDI
- Model / Reference
- LS-758-24 FDA UDI
- Description
- Trial, 16L x 18W x 11-12H x 12°, SST FDA UDI
Identifiers
- Primary DI / UDI-DI
- M711LS758240 FDA UDI
- 510(k) Number
- K231899 FDA UDI
- FDA Product Code
- ODP FDA UDI
- GMDN Term
- Spinal implant trial 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 16 Millimeter FDA UDIWidth — 18 Millimeter FDA UDIAngle — 12 degree FDA UDI
Category: Spinal implant trial
HAtetracell™-C by Innovasis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 ac7eb6be-6bf6-4368-a2c7-589dcf90d638 36 fields · synced May 31, 2026