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Xrl

FDA UDI

Class II (US FDA UDI)

by Synthes

Identity

Trade Name
XRL FDA UDI
Generic Name
Spinal implant trial FDA UDI
Device Name
XRL MEDIUM TRIAL-ENDPLATE 21MM X 24MM/-10 DEG FDA UDI
Model / Reference
03.807.531 FDA UDI
Description
XRL MEDIUM TRIAL-ENDPLATE 21MM X 24MM/-10 DEG FDA UDI

Identifiers

Catalog Number
03807531 FDA UDI
Primary DI / UDI-DI
10705034723631 FDA UDI
510(k) Number
K103320 FDA UDI
FDA Product Code
MQP FDA UDI
GMDN Term
Spinal implant trial FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3060 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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Spinal implant trial

Xrl by Synthes — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spinal implant trial.

Cleared under the same submission

K103320 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Synthes

Sources (1)

  • FDA UDI c72bcb2d-9ea4-4172-b28f-450ce88766a3 36 fields · synced May 30, 2026