Quantum

FDA UDI

Class II (US FDA UDI)

by In2bones

Identity

Trade Name: QUANTUM FDA UDI
Generic Name: Fixed-bearing total ankle prosthesis FDA UDI
Device Name: QUANTUM Fixed Insert Implant Size 5 Left 8 mm FDA UDI
Model / Reference: M50 SU258 FDA UDI
Description: QUANTUM Fixed Insert Implant Size 5 Left 8 mm FDA UDI

Identifiers

Catalog Number: M50 SU258 FDA UDI
Primary DI / UDI-DI: 03701337602215 FDA UDI
510(k) Number: K191380 FDA UDI
FDA Product Code: HSN FDA UDI
GMDN Term: Fixed-bearing total ankle prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3110 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 40.57 Millimeter FDA UDI
Length — 34 Millimeter FDA UDI

Category: Fixed-bearing total ankle prosthesis

Quantum by In2bones — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Fixed-bearing total ankle prosthesis.

INBONE — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
APEX 3D S Total Ankle Replacement System — Paragon 28 · Class II
INFINITY — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
INFINITY™ EVERLAST™ — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
Salto Talaris® — Ascension Orthopedics, Inc. · Class II
APEX 3D Total Ankle Replacement System — Paragon 28 · Class II
XT Revision Ankle Replacement System — Smith & Nephew, Inc. · Class II
Salto Talaris Total Ankle Prosthesis — Smith & Nephew, Inc. · Class II

Cleared under the same submission

K191380 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 II	Pending data

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Manufacturer

Manufacturer: In2bones

Sources (1)

FDA UDI 8a8dfcb1-8642-48af-8a29-e8a602a4cc64 37 fields · synced Jun 8, 2026