Synicem 48M Hip Trial FDA

FDA UDI

Class I (US FDA UDI)

by Biocomposites Ltd

Identity

Trade Name: Synicem 48M Hip Trial FDA FDA UDI
Generic Name: Hip revision prosthesis trial FDA UDI
Device Name: Reusable Hip Trial Spacer allows for the selection of the correct hip spacer to avoid manipulation prior to implantation during a 2-step revision hip arthroplasty. Reproduce the shape & size of the corresponding spacers. Provided non-sterile. Medical or surgical support personnel using the “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: 885412 FDA UDI
Description: Reusable Hip Trial Spacer allows for the selection of the correct hip spacer to avoid manipulation prior to implantation during a 2-step revision hip arthroplasty. Reproduce the shape & size of the corresponding spacers. Provided non-sterile. Medical or surgical support personnel using the “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: 885412 FDA UDI
Primary DI / UDI-DI: 15060155712267 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Hip 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Hip revision prosthesis trial

Synicem 48M Hip Trial FDA by Biocomposites Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hip revision prosthesis trial.

Prosthesis Trial — ADLER ORTHO SPA · Class I
Trial shaft — ADLER ORTHO SPA · Class I
Trial stem — ADLER ORTHO SPA · Class I
Prosthesis Trial — ADLER ORTHO SPA · Class I
Trial collar — ADLER ORTHO SPA · Class I
Trial stem — ADLER ORTHO SPA · Class I
InterSpace Tapered Wedge Stem Trial — Tecres · Class I
Trial shaft — ADLER ORTHO SPA · Class I

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 I	Pending data

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Manufacturer

Manufacturer: Biocomposites Ltd

Sources (1)

FDA UDI 90ae2c5e-77ac-4abd-8f98-81c98713c4a0 36 fields · synced May 30, 2026