13mm Integrated Hip Fastener 105mm 317-10105

GUDID 00816950028717

13mm Integrated Hip Fastener 105mm

SMV SCIENTIFIC LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID00816950028717
NIH Device Record Key8ae15859-09af-4574-b6ba-598ad922bc73
Commercial Distribution StatusIn Commercial Distribution
Brand Name13mm Integrated Hip Fastener 105mm
Version Model Number317-10105
Catalog Number317-10105
Company DUNS089645059
Company NameSMV SCIENTIFIC LLC
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com
Phone1-800-969-0639
Emailquality@osteocentric.com

Device Dimensions

Outer Diameter13 Millimeter
Length105 Millimeter
Outer Diameter13 Millimeter
Length105 Millimeter
Outer Diameter13 Millimeter
Length105 Millimeter
Outer Diameter13 Millimeter
Length105 Millimeter
Outer Diameter13 Millimeter
Length105 Millimeter
Outer Diameter13 Millimeter
Length105 Millimeter
Outer Diameter13 Millimeter
Length105 Millimeter
Outer Diameter13 Millimeter
Length105 Millimeter
Outer Diameter13 Millimeter
Length105 Millimeter
Outer Diameter13 Millimeter
Length105 Millimeter
Outer Diameter13 Millimeter
Length105 Millimeter
Outer Diameter13 Millimeter
Length105 Millimeter
Outer Diameter13 Millimeter
Length105 Millimeter
Outer Diameter13 Millimeter
Length105 Millimeter
Outer Diameter13 Millimeter
Length105 Millimeter
Outer Diameter13 Millimeter
Length105 Millimeter
Outer Diameter13 Millimeter
Length105 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100816950028717 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDODevice, Fixation, Proximal Femoral, Implant

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816950028717]

Moist Heat or Steam Sterilization


[00816950028717]

Moist Heat or Steam Sterilization


[00816950028717]

Moist Heat or Steam Sterilization


[00816950028717]

Moist Heat or Steam Sterilization


[00816950028717]

Moist Heat or Steam Sterilization


[00816950028717]

Moist Heat or Steam Sterilization


[00816950028717]

Moist Heat or Steam Sterilization


[00816950028717]

Moist Heat or Steam Sterilization


[00816950028717]

Moist Heat or Steam Sterilization


[00816950028717]

Moist Heat or Steam Sterilization


[00816950028717]

Moist Heat or Steam Sterilization


[00816950028717]

Moist Heat or Steam Sterilization


[00816950028717]

Moist Heat or Steam Sterilization


[00816950028717]

Moist Heat or Steam Sterilization


[00816950028717]

Moist Heat or Steam Sterilization


[00816950028717]

Moist Heat or Steam Sterilization


[00816950028717]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-17
Device Publish Date2021-05-07

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00810074300056 - 4.0 x 22mm Screw Super Fastener, ST2023-06-20 4.0 x 22mm Screw Super Fastener, ST
00810074300063 - 4.0 x 24mm Screw Super Fastener, ST2023-06-20 4.0 x 24mm Screw Super Fastener, ST
00810074300070 - 4.0 x 26mm Screw Super Fastener, ST2023-06-20 4.0 x 26mm Screw Super Fastener, ST

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