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ZSFab Cervical Interbody System

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K202488

by Zsfab, Inc.

Identity

Trade Name
ZSFab Cervical Interbody System FDA UDI
Generic Name
Metallic spinal interbody fusion cage FDA UDI
Device Name
Cervical 14Dx16Wx09HX7° FDA UDI
Model / Reference
14160907 FDA UDI
Description
Cervical 14Dx16Wx09HX7° FDA UDI

Identifiers

Primary DI / UDI-DI
00850035165188 FDA UDI
510(k) Number
K202488 FDA 510(k)FDA UDI
FDA Product Code
ODP FDA 510(k)FDA UDI
GMDN Term
Metallic spinal interbody fusion cage FDA UDI

Classification

Device Class
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 888.3080 FDA 510(k)
Regulation Number
888.3080 FDA 510(k)FDA UDI
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Depth — 14 Millimeter FDA UDI
Width — 16 Millimeter FDA UDI
Height — 9 Millimeter FDA UDI
Angle — 7 degree FDA UDI

ZSFab Cervical Interbody System by Zsfab, Inc. — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Zsfab, Inc.

Sources (2)

  • FDA 510(k) K202488 24 fields · synced Jun 18, 2026
  • FDA UDI 6539e780-eae5-49d8-bdc3-cf9c0fa26bf7 35 fields · synced May 27, 2026