FDA.reportPublic FDA data

Synicem Shoulder Spacer Trial Case (marked)

Primary DI
15060155712717
Brand
Synicem Shoulder Spacer Trial Case (marked)
Company
BIOCOMPOSITES LTD
Model
515092
Catalog number
515092
Device description
Synicem Shoulder Spacer Trial Case (marked)
Published
2025-07-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15060155712717PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1506015571271715060155712717

GMDN Terms#

Term, Definition table
TermDefinition
Shoulder revision prosthesis trialA copy of a final shoulder revision prosthesis, in the form of a combined humeral stem and head, designed to be used before revision implant surgery to validate the proper size of the permanent prosthesis required by the patient and to ensure its proper orientation and positioning. It is one of a set, or a set, of graduated sizes and is typically made of metal and/or polymer. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+441782338580info@biocomposites.com

Regulatory Flags#

DUNS number
424382307
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15060155712205Synicem Knee Spacer Trial Tray with Trials8820248820242025-07-08
15060155712328Synicem 58 Knee Trial FDA8854188854182025-07-08
15060155712342Synicem 65 Knee Trial FDA8854198854192025-07-08
15060155712366Synicem 72 Knee Trial FDA8854208854202025-07-08
15060155712380Synicem 79 Knee Trial FDA8854218854212025-07-08
15060155712700Synicem Knee Spacer Trial Case (marked)5150905150902025-07-08
15060155712021Synicem Hip Spacer 40C8854308854302025-07-08
15060155712038Synicem Hip Spacer 48C8854318854312025-07-08
15060155712045Synicem Hip Spacer 56C8854328854322025-07-08
15060155712052Synicem Hip Spacer 40CXL8854338854332025-07-08
15060155712069Synicem Hip Spacer 48CXL8854348854342025-07-08
15060155712076Synicem Hip Spacer 56CXL8854358854352025-07-08
15060155712083Synicem Hip Spacer 48M8854368854362025-07-08
15060155712090Synicem Hip Spacer 56M8854378854372025-07-08
15060155712106Synicem Hip Spacer Trial Tray Regular with Trials8820228820222025-07-08
15060155712113Synicem Hip Spacer Trial Tray XL with Trials8820238820232025-07-08
15060155712120Synicem Knee Spacer R588854388854382025-07-08
15060155712137Synicem Knee Spacer L588854398854392025-07-08
15060155712144Synicem Knee Spacer R658854408854402025-07-08
15060155712151Synicem Knee Spacer L658854418854412025-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000880118MSB Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-10-23
00842528130056OSTEOMEDOSTEOMED LLCLXH2026-10-23
00888867550391Arthrex®ARTHREX, INC.LXH2026-10-23
00888867550407Arthrex®ARTHREX, INC.LXH2026-10-23
00888867550414Arthrex®ARTHREX, INC.LXH2026-10-23
00888867550421Arthrex®ARTHREX, INC.LXH2026-10-23
04251631412144BEE PLIFNGMedical GmbHLXH2026-10-23
M739153997700Cross Connector DriverCAPTIVA SPINE, INC.LXH2026-10-23
M739153998800Cross Connector Counter TorqueCAPTIVA SPINE, INC.LXH2026-10-23
M739243501000Blade DilatorCAPTIVA SPINE, INC.LXH2026-10-23
M739243502000Parallel GuideCAPTIVA SPINE, INC.LXH2026-10-23
M739243503000In-Line HandleCAPTIVA SPINE, INC.LXH2026-10-23
M739243504000Tissue DilatorCAPTIVA SPINE, INC.LXH2026-10-23
M739243505000Tissue ProtectorCAPTIVA SPINE, INC.LXH2026-10-23
M739243506000Adjustable Parallel GuideCAPTIVA SPINE, INC.LXH2026-10-23
M739243507000Impaction SleeveCAPTIVA SPINE, INC.LXH2026-10-23
M739243508000Self-Feeding DrillCAPTIVA SPINE, INC.LXH2026-10-23
M739243509000Implant Filling TubeCAPTIVA SPINE, INC.LXH2026-10-23
M739243511000Plunger RodCAPTIVA SPINE, INC.LXH2026-10-23
M739243512000Cannulated Drill, 7mmCAPTIVA SPINE, INC.LXH2026-10-23
M7399830151066mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M7399830151077mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M7399830151088mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M7399830151099mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M73998301511010mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M73998301511111mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M73998301511212mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M739983101200Coupling - Square ConnectCAPTIVA SPINE, INC.LXH2026-10-23
M739983240300Impaction T-HandleCAPTIVA SPINE, INC.LXH2026-10-23
M739985202530Marking PinCAPTIVA SPINE, INC.LXH2026-10-23