FDA.reportPublic FDA data

Biosteon® IntraLine®

Primary DI
15060155711208
Brand
Biosteon® IntraLine®
Company
BIOCOMPOSITES LTD
Model
3910-200-085
Catalog number
3910-200-085
Device description
The Biosteon® IntraLine® 6.5mm HA/PLLA Needled Suture Anchor with two #2 Force Fibre®, is a single use device. It is made from a resorbable composite which will gradually be resorbed into the body. This function however is patient dependent. The device is supplied sterile. The device is intended to secure a suture or sutures to bone that are then used to reattach damaged soft tissue in orthopaedic procedures in the shoulder, foot/ankle, knee, hand/wrist, elbow and pelvis. The device is supplied with stainless steel needles and polyethylene sutures.
Published
2015-06-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
35060155711202PackageGS15In Commercial Distribution
15060155711208PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3506015571120235060155711202
1506015571120815060155711208

GMDN Terms#

Term, Definition table
TermDefinition
Bioabsorbable orthopaedic bone screw"A small, threaded, implantable rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that is chemically degraded and typically absorbed via natural body processes (e.g., degradable polymers). There are several kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded. A ""lag screw"" can be any of these used to obtain compression across bone fragments."

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Width6.5Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius47 Degrees Celsius
Storage Environment Temperature39 Degrees Fahrenheit117 Degrees Fahrenheit

Contacts#

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

Regulatory Flags#

DUNS number
424382307
Device count
1
Lot or batch
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

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