Identity
- Trade Name
- Indy FDA UDI
- Generic Name
- Orthopaedic fixation implant alignment tool FDA UDI
- Device Name
- Tamp, Indy ALIF FDA UDI
- Model / Reference
- 1020-0040 FDA UDI
- Description
- Tamp, Indy ALIF FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00843210143866 FDA UDI
- FDA Product Code
- HWJ FDA UDI
- GMDN Term
- Orthopaedic fixation implant alignment tool 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
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
Yes
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: Orthopaedic fixation implant alignment tool
Indy by Altus Spine — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic fixation implant alignment tool.
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- Easyspine — Ldr Spine USA · Class I
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 |
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Manufacturer
- Manufacturer
- Altus Spine
Sources (1)
- FDA UDI 30bc433e-41f5-46b2-8f4b-fd1bd5c2740a 34 fields · synced May 30, 2026