Synicem 48H Shoulder Trial FDA 885423

GUDID 15060155712403

Reusable Shoulder Trial Spacer allows for the selection of the correct shoulder spacer to avoid manipulation prior to implantation during a 2-step revision shoulder arthroplasty. Reproduce the shape & size of the corresponding spacers. Provided non-sterile. Medical or surgical support personnel using the “shoulder Trial Spacer” should familiarize themselves with the product within the context of their duties & responsibilities prior to use. These accessories are for momentary use.

BIOCOMPOSITES LTD

Shoulder revision prosthesis trial
Primary Device ID15060155712403
NIH Device Record Keyc4bab8fa-064d-44d5-8abd-51bcc1f153a3
Commercial Distribution StatusIn Commercial Distribution
Brand NameSynicem 48H Shoulder Trial FDA
Version Model Number885423
Catalog Number885423
Company DUNS424382307
Company NameBIOCOMPOSITES LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com

Device Identifiers

Device Issuing AgencyDevice ID
GS115060155712403 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[15060155712403]

Moist Heat or Steam Sterilization

[15060155712403]

Moist Heat or Steam Sterilization

[15060155712403]

Moist Heat or Steam Sterilization

[15060155712403]

Moist Heat or Steam Sterilization

[15060155712403]

Moist Heat or Steam Sterilization

[15060155712403]

Moist Heat or Steam Sterilization

[15060155712403]

Moist Heat or Steam Sterilization

[15060155712403]

Moist Heat or Steam Sterilization

[15060155712403]

Moist Heat or Steam Sterilization

[15060155712403]

Moist Heat or Steam Sterilization

[15060155712403]

Moist Heat or Steam Sterilization

[15060155712403]

Moist Heat or Steam Sterilization

[15060155712403]

Moist Heat or Steam Sterilization

[15060155712403]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-16
Device Publish Date2025-07-08

Devices Manufactured by BIOCOMPOSITES LTD

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15060155712038 - Synicem Hip Spacer 48C2025-07-16 Charnley Stem Type, 48mm Head, 130 mm Stem Length. Temporary implant which main function is to preserve the articular space duri
15060155712045 - Synicem Hip Spacer 56C2025-07-16 Charnley Stem Type, 56mm Head, 130 mm Stem Length. Temporary implant which main function is to preserve the articular space duri
15060155712052 - Synicem Hip Spacer 40CXL2025-07-16 Charnley Stem Type, 40mm Head, 250 mm Stem Length. Temporary implant which main function is to preserve the articular space duri
15060155712069 - Synicem Hip Spacer 48CXL2025-07-16 Charnley Stem Type, 48mm Head, 250mm Stem Length Temporary implant which main function is to preserve the articular space durin
15060155712076 - Synicem Hip Spacer 56CXL2025-07-16 Charnley Stem Type, 56mm Head, 250 mm Stem Length. Temporary implant which main function is to preserve the articular space duri
15060155712083 - Synicem Hip Spacer 48M2025-07-16 Muller Stem Type, 48mm Head, 120 mm Stem Length. Temporary implant which main function is to preserve the articular space during
15060155712090 - Synicem Hip Spacer 56M2025-07-16 Muller Stem Type, 56mm Head, 127mm Stem Length. Temporary implant which main function is to preserve the articular space during
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