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Acf

FDA UDI

Class I (US FDA UDI)

by Synthes

Identity

Trade Name
ACF FDA UDI
Generic Name
Spinal implant trial FDA UDI
Device Name
SPN CORRECTION ACF DETACHABLE TRIAL SPACER LORDOTIC 12MM FDA UDI
Model / Reference
389.098 FDA UDI
Description
SPN CORRECTION ACF DETACHABLE TRIAL SPACER LORDOTIC 12MM FDA UDI

Identifiers

Catalog Number
389098 FDA UDI
Primary DI / UDI-DI
10705034774527 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Spinal implant trial FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 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

Yes

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

Acf by Synthes — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spinal implant trial.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Synthes

Sources (1)

  • FDA UDI 33d4a4cc-5bc4-403d-98d7-e5e02337cf81 35 fields · synced Jun 8, 2026