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Humelock Reversed

FDA UDI

Class II (US FDA UDI)

by Fx Solutions

Identity

Trade Name
Humelock Reversed FDA UDI
Generic Name
Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
Device Name
HOLE SAW Ø26mm H14mm WITH DRILL Ø8mm/HUDSON FDA UDI
Model / Reference
961-0003 FDA UDI
Description
HOLE SAW Ø26mm H14mm WITH DRILL Ø8mm/HUDSON FDA UDI

Identifiers

Primary DI / UDI-DI
03701037321133 FDA UDI
510(k) Number
K162455 FDA UDI
FDA Product Code
PHX FDA UDI
HSD FDA UDI
GMDN Term
Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3660 FDA UDI
888.3690 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic surgical procedure kit, non-medicated, reusable

Humelock Reversed by Fx Solutions — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic surgical procedure kit, non-medicated, reusable.

Cleared under the same submission

K162455 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Fx Solutions

Sources (1)

  • FDA UDI f1e1217b-f056-4f56-b6dd-734327f54b81 34 fields · synced Jun 8, 2026