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Tip, Modular Stem, Smith & Nephew (S9HIP-MOD Shukla Medical Modular-HIP/ Univer…

EUDAMEDFDA 510(k)

Class I (EU MDR)

Ref 120-05Model 120-04

by S. S. White Technologies Inc/DBA Shukla Medical

Identity

Trade Name
Tip, Modular Stem, Smith & Nephew (S9HIP-MOD Shukla Medical Modular-HIP/ Universal Hip Implant Extraction Solution) EUDAMED
Device Name
Tip, Modular Stem, Stryker (S9HIP-MOD Shukla Medical Modular-HIP/ Universal Hip Implant Extraction Solution) EUDAMED
Model / Reference
120-04 EUDAMED
120-05 EUDAMED

Identifiers

Primary DI / UDI-DI
+B756120050 EUDAMED
Basic UDI-DI
++B756S9HIPMODEXTF4 EUDAMED
Direct Marketing DI
+B756120050 EUDAMED
EMDN Code
L091101 ORTHOPAEDIC PROSTHESES AND TRAUMATOLOGICAL IMPLANTS EXTRACTORS, REUSABLE EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Northern Ireland EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

Yes

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Tip, Modular Stem, Smith & Nephew (S9HIP-MOD Shukla Medical Modular-HIP/ Univer… by S. S. White Technologies Inc/DBA Shukla Medical — Class I — FDA_510K, MDR…

Manufacturer's product page: Mod Hip

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
S. S. White Technologies Inc/DBA Shukla Medical
EUDAMED SRN
US-MF-000007058
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (2)

  • EUDAMED 3bf34d76-1528-45f8-9305-fcfb3aa0f327 61 fields · synced Oct 6, 2026
  • FDA 510(k) K042127 1 fields · synced May 18, 2026