Identity
- Trade Name
- IDYS-C® ZP 3DTi FDA UDI
- Generic Name
- Spinal implant trial FDA UDI
- Device Name
- WEDGE TRIAL FDA UDI
- Model / Reference
- 44714408 FDA UDI
- Description
- WEDGE TRIAL FDA UDI
Identifiers
- Catalog Number
- 44714408 FDA UDI
- Primary DI / UDI-DI
- 03700780636297 FDA UDI
- 510(k) Number
- K212562 FDA UDI
- FDA Product Code
- ODP FDA UDIOVE 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
Yes
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: Spinal implant trial
IDYS-C® ZP 3DTi by Clariance, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K212562 also covers:
- IDYS-C® ZP 3DTi — Clariance, Inc.
- IDYS-C® ZP 3DTi — Clariance, Inc.
- IDYS-C® ZP 3DTi — Clariance, Inc.
- IDYS-C® ZP 3DTi — Clariance, Inc.
- IDYS-C® ZP 3DTi — Clariance, Inc.
- IDYS-C® ZP 3DTi — Clariance, Inc.
- IDYS-C® ZP 3DTi — Clariance, Inc.
- IDYS-C® ZP 3DTi — Clariance, Inc.
- IDYS-C® ZP 3DTi — Clariance, Inc.
- IDYS-C® ZP 3DTi — Clariance, Inc.
- IDYS-C® ZP 3DTi — Clariance, Inc.
- IDYS-C® ZP 3DTi — Clariance, 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
- Clariance, Inc.
Sources (1)
- FDA UDI 2e7f02ea-c4d0-45b3-90eb-0be3b51ff845 37 fields · synced Jun 8, 2026