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Concorde

FDA UDI

Class II (US FDA UDI)

by Depuy Spine, Inc.

Identity

Trade Name
CONCORDE FDA UDI
Generic Name
Spinal implant trial FDA UDI
Device Name
CONCORDE INLINE SPINAL SYSTEM PARALLEL TRIAL 9 x 7 x 21/25mm, 0 DEGREES FDA UDI
Model / Reference
287821007 FDA UDI
Description
CONCORDE INLINE SPINAL SYSTEM PARALLEL TRIAL 9 x 7 x 21/25mm, 0 DEGREES FDA UDI

Identifiers

Catalog Number
287821007 FDA UDI
Primary DI / UDI-DI
10705034305554 FDA UDI
510(k) Number
K110694 FDA UDI
FDA Product Code
MAX FDA UDI
MQP FDA UDI
GMDN Term
Spinal implant trial FDA UDI

Classification

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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Concorde by Depuy Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K110694 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Depuy Spine, Inc.

Sources (1)

  • FDA UDI 25c3edbd-2819-4c68-867c-1688b33010af 37 fields · synced Jun 1, 2026