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4cis Vane Spine System

FDA UDI

Class II (US FDA UDI)

by Alphanox Co., Ltd.

Identity

Trade Name
4CIS VANE SPINE SYSTEM FDA UDI
Generic Name
Spinal bone screw, non-bioabsorbable FDA UDI
Device Name
VANE 5.7 Poly Reduction Cannula Pedicle Screw, 5.5x25mm FDA UDI
Model / Reference
4016-5525 FDA UDI
Description
VANE 5.7 Poly Reduction Cannula Pedicle Screw, 5.5x25mm FDA UDI

Identifiers

Catalog Number
4016-5525 FDA UDI
Primary DI / UDI-DI
08806373577277 FDA UDI
510(k) Number
K121615 FDA UDI
FDA Product Code
MNH FDA UDI
MNI FDA UDI
GMDN Term
Spinal bone screw, non-bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3070 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

4cis Vane Spine System by Alphanox Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K121615 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Alphanox Co., Ltd.

Sources (1)

  • FDA UDI 3c96192b-80ac-4a41-8160-5b6f2b7a4a1b 36 fields · synced Jun 1, 2026