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Zenius Spinal System

FDA UDI

Class II (US FDA UDI)

by Medyssey Co., Ltd.

Identity

Trade Name
Zenius Spinal System FDA UDI
Generic Name
Spinal bone screw, non-bioabsorbable FDA UDI
Device Name
Cannulated Poly-Axial Screw 5.5mm x 50mm, 5.5mm Rod, Long Reduction-Ø12mm Type FDA UDI
Model / Reference
ZSTXCP5550 FDA UDI
Description
Cannulated Poly-Axial Screw 5.5mm x 50mm, 5.5mm Rod, Long Reduction-Ø12mm Type FDA UDI

Identifiers

Primary DI / UDI-DI
08809625989545 FDA UDI
510(k) Number
K171526 FDA UDI
FDA Product Code
NKB 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

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

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

Zenius Spinal System by Medyssey Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K171526 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medyssey Co., Ltd.

Sources (1)

  • FDA UDI 8d67f7a3-4d0e-4cef-8abd-e0010d46b079 35 fields · synced May 31, 2026