Ortho Solutions Succession Afn System

FDA UDI

Class I (US FDA UDI)

by Ortho Solutions Holdings Limited

Identity

Trade Name: ORTHO SOLUTIONS SUCCESSION AFN SYSTEM FDA UDI
Generic Name: Surgical depth gauge, reusable FDA UDI
Device Name: SUCCESSION DEPTH GAUGE FDA UDI
Model / Reference: OS353017-NS FDA UDI
Description: SUCCESSION DEPTH GAUGE FDA UDI

Identifiers

Catalog Number: OS353017-NS FDA UDI
Primary DI / UDI-DI: 05055662971057 FDA UDI
510(k) Number: K250622 FDA UDI
FDA Product Code: HTJ FDA UDI
GMDN Term: Surgical depth gauge, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4300 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical depth gauge, reusable

Ortho Solutions Succession Afn System by Ortho Solutions Holdings Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical depth gauge, reusable.

Depth Gauge — I.T.S. GmbH · Class I
FO NX Nail System — FIELD ORTHOPAEDICS PTY LTD · Class I
FO Micro Screw System — FIELD ORTHOPAEDICS PTY LTD · Class I
Summa Orthopaedics System Surgical Instrument — Jeil Medical Corporation · Class I
Trigen — Smith & Nephew, Inc. · Class I
HOOK TIP DEPTH GAUGE CLAVICLE SYSTEM — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class I
MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
Summa Orthopaedics System Surgical Instrument — Jeil Medical Corporation · Class I

Cleared under the same submission

K250622 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Ortho Solutions Holdings Limited

Sources (1)

FDA UDI e24d1146-639e-43e6-980b-a4772e715d37 36 fields · synced Jun 6, 2026