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Solanas

FDA UDI

Class I (US FDA UDI)

by Alphatec Spine, Inc.

Identity

Trade Name
Solanas FDA UDI
Generic Name
Orthopaedic implantable-device cutter FDA UDI
Device Name
3.3mm ROD CUTTER FDA UDI
Model / Reference
63916 FDA UDI
Description
3.3mm ROD CUTTER FDA UDI

Identifiers

Primary DI / UDI-DI
00844856007604 FDA UDI
FDA Product Code
HTZ FDA UDI
GMDN Term
Orthopaedic implantable-device cutter 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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic implantable-device cutter

Solanas by Alphatec Spine, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic implantable-device cutter.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Alphatec Spine, Inc.

Sources (1)

  • FDA UDI 47f462cc-4e33-4daf-8c11-6ca65614b5e2 34 fields · synced Jun 8, 2026