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Synicem 58 Knee Trial FDA

FDA UDI

Class I (US FDA UDI)

by Biocomposites Ltd

Identity

Trade Name
Synicem 58 Knee Trial FDA FDA UDI
Generic Name
Knee revision prosthesis trial FDA UDI
Device Name
Reusable Knee Trial Spacer allows for the selection of the correct knee spacer to avoid manipulation prior to implantation during a 2-step revision knee arthroplasty. Reproduce the shape & size of the corresponding spacers. Provided non-sterile. Medical or surgical support personnel using the “Knee Trial Spacer” should familiarize themselves with the product within the context of their duties & responsibilities prior to use. These accessories are for momentary use. FDA UDI
Model / Reference
885418 FDA UDI
Description
Reusable Knee Trial Spacer allows for the selection of the correct knee spacer to avoid manipulation prior to implantation during a 2-step revision knee arthroplasty. Reproduce the shape & size of the corresponding spacers. Provided non-sterile. Medical or surgical support personnel using the “Knee Trial Spacer” should familiarize themselves with the product within the context of their duties & responsibilities prior to use. These accessories are for momentary use. FDA UDI

Identifiers

Catalog Number
885418 FDA UDI
Primary DI / UDI-DI
15060155712328 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Knee revision prosthesis 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

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Knee revision prosthesis trial

Synicem 58 Knee Trial FDA by Biocomposites Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Knee revision prosthesis trial.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biocomposites Ltd

Sources (1)

  • FDA UDI 5db745ad-ff7e-4d19-91cb-28980b7b8c1f 35 fields · synced Jun 1, 2026