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 PARALLEL IMPLANT 11 x 11 x 23mm, 0 DEGREES FDA UDI
Model / Reference: 187823211 FDA UDI
Description: CONCORDE BULLET SPINAL SYSTEM PARALLEL IMPLANT 11 x 11 x 23mm, 0 DEGREES FDA UDI

Identifiers

Catalog Number: 187823211 FDA UDI
Primary DI / UDI-DI: 10705034139449 FDA UDI
510(k) Number: K081917 FDA UDI
K110694 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: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Polymeric spinal interbody fusion cage

The CONCORDE device is a type of spinal interbody fusion cage designed to provide mechanical stability and support for bone fusion in patients undergoing spinal surgery. Made from non-bioabsorbable synthetic polymer, it features a hollow, porous design that allows for therapeutic spinal bone fusion to occur. The device includes fixation screws and devices associated with implantation, making it an ideal solution for intervertebral disc replacement.

Similar devices

Also classified as Polymeric spinal interbody fusion cage.

L-Box® — Innovasis, Inc. · Class II
CoRoent — Nuvasive, Inc. · Class II
Novel Spinal Spacer System — ALPHATEC SPINE, INC. · Class II
S-LIFT® — SPINEFRONTIER, INC. · Class II
Peridot Intervertebral body fusion system — GBS Commonwealth Co., Ltd. · Class II
TAURUS PEEK Cage System — Medyssey Co., Ltd. · Class II
Cross-Fuse® II PEEK IBF System — Rti Surgical, Inc. · Class II
Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II

Cleared under the same submission

K081917 also covers:

K110694 also covers:

K173787 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: Medos International Sàrl

Sources (1)

FDA UDI 443b3318-d412-419e-b623-bb61f6c14d36 36 fields · synced Jul 13, 2026