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Kheiron

FDA UDI

Class II (US FDA UDI)

by S.m.a.i.o

Identity

Trade Name
KHEIRON FDA UDI
Generic Name
Spinal bone screw head/rod adaptor FDA UDI
Device Name
Large, closed derotation offset connector FDA UDI
Model / Reference
24PW56635 FDA UDI
Description
Large, closed derotation offset connector FDA UDI

Identifiers

Catalog Number
24PW56635 FDA UDI
Primary DI / UDI-DI
03701313005139 FDA UDI
FDA Product Code
NKB FDA UDI
GMDN Term
Spinal bone screw head/rod adaptor FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3070 FDA UDI
Commercial Distribution
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

Dimensions & Sizes

Size
Length — 70 Millimeter FDA UDI
Outer Diameter — 7.5 Millimeter FDA UDI

Category: Spinal bone screw head/rod adaptor

Kheiron by S.m.a.i.o — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spinal bone screw head/rod adaptor.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
S.m.a.i.o

Sources (1)

  • FDA UDI b6a9d755-c5b6-4120-a4a1-d6397726eb29 36 fields · synced May 30, 2026