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Kheiron

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref 24PW45055

by S.m.a.i.o

Identity

Trade Name
KHEIRON EUDAMEDFDA UDI
Generic Name
Spinal bone screw, non-bioabsorbable FDA UDI
Device Name
Vis pédiculaire Ø4.5 L55mm EUDAMED
Model / Reference
24PW45055 EUDAMEDFDA UDI

Identifiers

Catalog Number
24PW45055 FDA UDI
Primary DI / UDI-DI
03701313000806 EUDAMEDFDA UDI
Basic UDI-DI
B-03701313000806 EUDAMED
510(k) Number
K201659 FDA UDI
FDA Product Code
NKB FDA UDI
EMDN Code
P09070302 THORACOLUMBOSACRAL FIXATION SYSTEMS EUDAMED
GMDN Term
Spinal bone screw, non-bioabsorbable FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
888.3070 FDA UDI
Market of Registration
France EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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 — 55 Millimeter FDA UDI
Outer Diameter — 4.5 Millimeter FDA UDI

Kheiron by S.m.a.i.o — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
S.m.a.i.o
EUDAMED SRN
FR-MF-000002399

Sources (2)

  • EUDAMED a601e95a-e712-49ce-9ea9-dbdab14a3f37 61 fields · synced Jul 15, 2026
  • FDA UDI 9ceaf492-445f-4c08-883f-6646b8e921b9 36 fields · synced May 30, 2026