Identity
- Trade Name
- Novel FDA UDI
- Generic Name
- Bone lever/elevator, reusable FDA UDI
- Device Name
- ROTATING DISTRACTOR, SIZE 10 FDA UDI
- Model / Reference
- 64010-010 FDA UDI
- Description
- ROTATING DISTRACTOR, SIZE 10 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00844856027107 FDA UDI
- FDA Product Code
- HTE FDA UDI
- GMDN Term
- Bone lever/elevator, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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: Bone lever/elevator, reusable
Novel by Alphatec Spine, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone lever/elevator, reusable.
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- Life Instruments — Life Instrument Corporation · Class I
- Arthrex® — Arthrex, Inc. · Class I
- Novo Surgical Inc — NOVO SURGICAL, INC. · Class I
- MILLENNIUM — AVALIGN TECHNOLOGIES, Inc. · 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
- Alphatec Spine, Inc.
Sources (1)
- FDA UDI b68102b3-6b55-40e2-8639-ea5c19f3cdcd 34 fields · synced Jun 8, 2026