10 X 82.5MM SI FUSION FASTENER CANN STERILE 202-10082-S

GUDID 00810097803381

10 X 82.5MM SI FUSION FASTENER CANN STERILE

Osteocentric Technologies, Inc.

Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated
Primary Device ID00810097803381
NIH Device Record Key9bfa1f3a-616d-48c8-ac0c-c924a1dec887
Commercial Distribution StatusIn Commercial Distribution
Brand Name10 X 82.5MM SI FUSION FASTENER CANN STERILE
Version Model Number202-10082-S
Catalog Number202-10082-S
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
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 Diameter10 Millimeter
Length82.5 Millimeter
Outer Diameter10 Millimeter
Length82.5 Millimeter
Outer Diameter10 Millimeter
Length82.5 Millimeter
Outer Diameter10 Millimeter
Length82.5 Millimeter
Outer Diameter10 Millimeter
Length82.5 Millimeter
Outer Diameter10 Millimeter
Length82.5 Millimeter
Outer Diameter10 Millimeter
Length82.5 Millimeter
Outer Diameter10 Millimeter
Length82.5 Millimeter
Outer Diameter10 Millimeter
Length82.5 Millimeter
Outer Diameter10 Millimeter
Length82.5 Millimeter
Outer Diameter10 Millimeter
Length82.5 Millimeter
Outer Diameter10 Millimeter
Length82.5 Millimeter
Outer Diameter10 Millimeter
Length82.5 Millimeter
Outer Diameter10 Millimeter
Length82.5 Millimeter
Outer Diameter10 Millimeter
Length82.5 Millimeter
Outer Diameter10 Millimeter
Length82.5 Millimeter
Outer Diameter10 Millimeter
Length82.5 Millimeter
Outer Diameter10 Millimeter
Length82.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100810097803381 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OURSacroiliac Joint Fixation

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-11
Device Publish Date2023-10-03

Devices Manufactured by Osteocentric Technologies, Inc.

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00810074307550 - 6.0 x 65mm Bone Screw Fastener ST2025-10-06 6.0 x 65mm Bone Screw Fastener ST
00810074308984 - 11 X 75mm LAG FASTENER2025-09-30 11 X 75mm LAG FASTENER
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
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