Identity
- Trade Name
- Avalign FDA UDI
- Generic Name
- Orthopaedic ball spike FDA UDI
- Device Name
- Ball Spike, straight, FDA UDI
- Model / Reference
- VM80-1986 FDA UDI
- Description
- Ball Spike, straight, FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190776076306 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic ball spike 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic ball spike
Avalign by AVALIGN TECHNOLOGIES, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic ball spike.
- OIC Intramedullary Nail System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II
- gSource — GSOURCE, LLC. · Class I
- gSource — GSOURCE, LLC. · Class I
- Bone Spike, Straight — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION · Class I
- SMR Shoulder — Limacorporate · Class II
- SMR Shoulder — Limacorporate · Class II
- Straight Ball Spike — I.T.S. GmbH · Class II
- OIC Intramedullary Nail System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II
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
- AVALIGN TECHNOLOGIES, Inc.
Sources (1)
- FDA UDI aa9e97b4-6a96-4ff9-b397-9fa2f8dc5b27 34 fields · synced May 30, 2026