13 X 80mm LAG FASTENER 324-13080

GUDID 00810189110052

13 X 80mm LAG FASTENER

Osteocentric Technologies, Inc.

Orthopaedic bone screw (non-sliding)
Primary Device ID00810189110052
NIH Device Record Key71651da9-9114-4d45-8a64-0d0f0b9ec3f5
Commercial Distribution StatusIn Commercial Distribution
Brand Name13 X 80mm LAG FASTENER
Version Model Number324-13080
Catalog Number324-13080
Company DUNS089645059
Company NameOsteocentric Technologies, Inc.
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

Device Dimensions

Outer Diameter13 Millimeter
Length80 Millimeter
Outer Diameter13 Millimeter
Length80 Millimeter
Outer Diameter13 Millimeter
Length80 Millimeter
Outer Diameter13 Millimeter
Length80 Millimeter
Outer Diameter13 Millimeter
Length80 Millimeter
Outer Diameter13 Millimeter
Length80 Millimeter
Outer Diameter13 Millimeter
Length80 Millimeter
Outer Diameter13 Millimeter
Length80 Millimeter
Outer Diameter13 Millimeter
Length80 Millimeter
Outer Diameter13 Millimeter
Length80 Millimeter
Outer Diameter13 Millimeter
Length80 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100810189110052 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDODevice, Fixation, Proximal Femoral, Implant

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810189110052]

Moist Heat or Steam Sterilization


[00810189110052]

Moist Heat or Steam Sterilization


[00810189110052]

Moist Heat or Steam Sterilization


[00810189110052]

Moist Heat or Steam Sterilization


[00810189110052]

Moist Heat or Steam Sterilization


[00810189110052]

Moist Heat or Steam Sterilization


[00810189110052]

Moist Heat or Steam Sterilization


[00810189110052]

Moist Heat or Steam Sterilization


[00810189110052]

Moist Heat or Steam Sterilization


[00810189110052]

Moist Heat or Steam Sterilization


[00810189110052]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-30
Device Publish Date2025-09-22

Devices Manufactured by Osteocentric Technologies, Inc.

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00810074309974 - 11 X 80mm LAG FASTENER2025-09-30 11 X 80mm LAG FASTENER
00810074309981 - 11 X 85mm LAG FASTENER2025-09-30 11 X 85mm LAG FASTENER
00810074309998 - 11 X 90mm LAG FASTENER2025-09-30 11 X 90mm LAG FASTENER
00810189110007 - 11 X 95mm LAG FASTENER2025-09-30 11 X 95mm LAG FASTENER
00810189110014 - 11 X 100mm LAG FASTENER2025-09-30 11 X 100mm LAG FASTENER
00810189110021 - 11 X 105mm LAG FASTENER2025-09-30 11 X 105mm LAG FASTENER
00810189110038 - 11 X 110mm LAG FASTENER2025-09-30 11 X 110mm LAG FASTENER

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