← Back to catalogue

Quantum

FDA UDI

Class II (US FDA UDI)

by In2bones

Identity

Trade Name
QUANTUM FDA UDI
Generic Name
Custom-made orthopaedic/craniofacial surgical guide FDA UDI
Device Name
QUANTUM PSI GUIDES FOR TOTAL ANKLE REPLACEMENT, US FDA UDI
Model / Reference
M05 PSI FDA UDI
Description
QUANTUM PSI GUIDES FOR TOTAL ANKLE REPLACEMENT, US FDA UDI

Identifiers

Catalog Number
M05 PSI FDA UDI
Primary DI / UDI-DI
03701337614355 FDA UDI
510(k) Number
K211883 FDA UDI
FDA Product Code
HSN FDA UDI
GMDN Term
Custom-made orthopaedic/craniofacial surgical guide 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

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: Custom-made orthopaedic/craniofacial surgical guide

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

Similar devices

Also classified as Custom-made orthopaedic/craniofacial surgical guide.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
In2bones

Sources (1)

  • FDA UDI 52b441cb-a932-4ec8-8c15-a31aba555dd6 36 fields · synced Jun 6, 2026