Identity
- Trade Name
- Alphatec Spine FDA UDI
- Generic Name
- General internal orthopaedic fixation system implantation kit FDA UDI
- Device Name
- Fistula Scissors EUDAMEDPOSTERIOR VERTEBRAL BODY PUNCH, WIDE FDA UDI
- Model / Reference
- 89000-06-125 EUDAMEDFDA UDI
- Description
- POSTERIOR VERTEBRAL BODY PUNCH, WIDE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190776148911 EUDAMEDFDA UDI
- Basic UDI-DI
- 0190776CUTBM EUDAMED
- Direct Marketing DI
- 00190776148911 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L090401 ORTHOPAEDIC SURGERY OSTEOTOMES, REUSABLE EUDAMED
- GMDN Term
- General internal orthopaedic fixation system implantation kit FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Bulgaria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
Yes
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Dimensions & Sizes
- Size
- Width — 25 Millimeter FDA UDI
Category: General internal orthopaedic fixation system implantation kit
Alphatec Spine by AVALIGN TECHNOLOGIES, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as General internal orthopaedic fixation system implantation kit.
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- AVALIGN TECHNOLOGIES, Inc.
Sources (2)
- FDA UDI 054d1450-6bda-4479-bcf9-41a40ab9d410 35 fields · synced Jun 19, 2026
- EUDAMED a43936a7-b8e7-4fef-b423-08bed8a52da7 61 fields · synced Jun 19, 2026