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Click'X

FDA UDI

Class II (US FDA UDI)

by Synthes (u.s.a.) Lp

Identity

Trade Name
Click'X FDA UDI
Generic Name
Bone-screw internal spinal fixation system, non-sterile FDA UDI
Device Name
8.0MM TI CLICK'X® PEDICLE SCR DUAL CORE 80MM THREAD LENGTH FDA UDI
Model / Reference
485.964 FDA UDI
Description
8.0MM TI CLICK'X® PEDICLE SCR DUAL CORE 80MM THREAD LENGTH FDA UDI

Identifiers

Catalog Number
485964 FDA UDI
Primary DI / UDI-DI
10705034782799 FDA UDI
FDA Product Code
NKB FDA UDI
KWP FDA UDI
MNH FDA UDI
MNI FDA UDI
KWQ FDA UDI
GMDN Term
Bone-screw internal spinal fixation system, non-sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3070 FDA UDI
888.3050 FDA UDI
888.3060 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

No

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

Click'X by Synthes (u.s.a.) Lp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Synthes (u.s.a.) Lp

Sources (1)

  • FDA UDI f8d0e518-b383-463e-9adc-814027394775 36 fields · synced May 29, 2026