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IO FiX

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref 118-46614

by Extremity Medical, LLC

Identity

Trade Name
IO FiX EUDAMEDFDA UDI
Generic Name
Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
Device Name
X-Post (60 deg) 4.6 x 14mm EUDAMED
X-Post (60 deg) 4.6 x 14 mm FDA UDI
Model / Reference
118-46614 EUDAMEDFDA UDI
Description
X-Post (60 deg) 4.6 x 14 mm FDA UDI

Identifiers

Primary DI / UDI-DI
00842078105542 EUDAMEDFDA UDI
Basic UDI-DI
B-00842078105542 EUDAMED
510(k) Number
K121349 FDA UDI
FDA Product Code
HWC FDA UDI
EMDN Code
P09120603 CANNULATED SCREWS EUDAMED
GMDN Term
Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
888.3040 FDA UDI
Market of Registration
Spain 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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

IO FiX by Extremity Medical, LLC — 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
Extremity Medical, LLC
EUDAMED SRN
US-MF-000018334
Authorised Representative
MDSS GmbH DE-AR-000005430

Sources (2)

  • EUDAMED 33bc558e-03b6-4d2f-925b-70e7f19f86a1 61 fields · synced Jun 9, 2026
  • FDA UDI 8cb358e2-cf4d-40af-b730-6674dacfc3fb 34 fields · synced May 30, 2026