Identity
- Trade Name
- NekSpine System, w/ Medium Support FDA UDI
- Generic Name
- Thoracic spine orthosis FDA UDI
- Device Name
- The NekSpine is intended for relief of back and neck pain, when looking down for extended periods of time, by providing a force that counteracts the effects of gravity on the head. The device is reusable and intended for short-term use. FDA UDI
- Model / Reference
- 1-1011-003 FDA UDI
- Description
- The NekSpine is intended for relief of back and neck pain, when looking down for extended periods of time, by providing a force that counteracts the effects of gravity on the head. The device is reusable and intended for short-term use. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810105030556 FDA UDI
- FDA Product Code
- IPT FDA UDI
- GMDN Term
- Thoracic spine orthosis FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3490 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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Thoracic spine orthosis
NekSpine System, w/ Medium Support by Composite Manufacturing, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Composite Manufacturing, Inc.
Sources (1)
- FDA UDI 25da8a39-e688-4f61-afc3-13abbe37091b 34 fields · synced May 30, 2026