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Concorde

FDA UDI

Class II (US FDA UDI)

by Medos International Sàrl

Identity

Trade Name
CONCORDE FDA UDI
Generic Name
Polymeric spinal interbody fusion cage FDA UDI
Device Name
CONCORDE BULLET SPINAL SYSTEM LORDOTIC IMPLANT 13 x 13 x 27mm, 5 DEGREES FDA UDI
Model / Reference
187827713 FDA UDI
Description
CONCORDE BULLET SPINAL SYSTEM LORDOTIC IMPLANT 13 x 13 x 27mm, 5 DEGREES FDA UDI

Identifiers

Catalog Number
187827713 FDA UDI
Primary DI / UDI-DI
10705034140308 FDA UDI
510(k) Number
K041722 FDA UDI
K081917 FDA UDI
K151773 FDA UDI
K173787 FDA UDI
FDA Product Code
MQP FDA UDI
MAX FDA UDI
GMDN Term
Polymeric spinal interbody fusion cage FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3060 FDA UDI
888.3080 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Concorde by Medos International Sàrl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K041722 also covers:

K081917 also covers:

K151773 also covers:

K173787 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medos International Sàrl

Sources (1)

  • FDA UDI d7f42f96-a043-44d5-a39c-5c1ff4845b42 37 fields · synced Jun 6, 2026