ComposiTCP™ 110026115

GUDID 03760154007245

Threaded anchor system Ø 6.5 mm with one Blue non-sliding suture and one White/Green sliding suture

S.B.M

Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Orthopaedic bone screw, bioabsorbable Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Bioabsorbable orthopaedic bone screw Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable
Primary Device ID03760154007245
NIH Device Record Key8dd80111-815b-4f88-b91f-01dfa6c75c3d
Commercial Distribution StatusIn Commercial Distribution
Brand NameComposiTCP™
Version Model NumberNon-sliding BroadBand
Catalog Number110026115
Company DUNS772462123
Company NameS.B.M
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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

Device Dimensions

Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter
Outer Diameter6.5 Millimeter

Operating and Storage Conditions

Storage Environment HumidityBetween 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment HumidityBetween 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment HumidityBetween 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment HumidityBetween 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment HumidityBetween 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment HumidityBetween 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment HumidityBetween 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment HumidityBetween 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment HumidityBetween 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment HumidityBetween 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment HumidityBetween 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment HumidityBetween 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment HumidityBetween 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment HumidityBetween 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment HumidityBetween 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment HumidityBetween 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment HumidityBetween 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment HumidityBetween 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment HumidityBetween 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment HumidityBetween 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment HumidityBetween 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment HumidityBetween 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment HumidityBetween 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment HumidityBetween 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment HumidityBetween 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment HumidityBetween 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment HumidityBetween 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment HumidityBetween 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment HumidityBetween 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment HumidityBetween 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment HumidityBetween 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment HumidityBetween 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment HumidityBetween 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment HumidityBetween 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment HumidityBetween 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment HumidityBetween 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment HumidityBetween 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment HumidityBetween 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment HumidityBetween 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment HumidityBetween 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment HumidityBetween 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment HumidityBetween 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment HumidityBetween 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment HumidityBetween 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment HumidityBetween 50 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 33 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS103760154007245 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAIFastener, Fixation, Biodegradable, Soft Tissue

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-07-22
Device Publish Date2019-07-12

On-Brand Devices [ComposiTCP™]

03760154007245Threaded anchor system Ø 6.5 mm with one Blue non-sliding suture and one White/Green sliding su
03760154007238Threaded anchor system Ø 5.5 mm with one Blue non-sliding suture and one White/Green sliding su
03760154007221Threaded anchor system Ø 4.5 mm with one Blue non-sliding suture and one White/Green sliding su
03760154008266Threaded anchor system Ø 6.5 mm
03760154008259Threaded anchor system Ø 5.5 mm
03760154008242Threaded anchor system Ø 4.5 mm
03760154008235Threaded anchor system for rotator cuff repair - CLASSIC - Ø 6.5 mm
03760154008228Threaded anchor system for rotator cuff repair - CLASSIC - Ø 5.5 mm
03760154008211Threaded anchor system for rotator cuff repair - CLASSIC - Ø 4.5 mm
03760154008280Ø 5.5 mm & Ø 6.5 mm suture anchor punch tap
03760154008273Ø4.5 mm suture anchor punch tap

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