8 X 60MM SI FUSION FASTENER CANN 202-08060

GUDID 00810097803084

8 X 60MM SI FUSION FASTENER CANN

Osteocentric Technologies, Inc.

Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated
Primary Device ID00810097803084
NIH Device Record Key5dc5dc7a-95f9-4ab2-86e9-d290d89bb7b6
Commercial Distribution StatusIn Commercial Distribution
Brand Name8 X 60MM SI FUSION FASTENER CANN
Version Model Number202-08060
Catalog Number202-08060
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
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 Diameter8 Millimeter
Length60 Millimeter
Outer Diameter8 Millimeter
Length60 Millimeter
Outer Diameter8 Millimeter
Length60 Millimeter
Outer Diameter8 Millimeter
Length60 Millimeter
Outer Diameter8 Millimeter
Length60 Millimeter
Outer Diameter8 Millimeter
Length60 Millimeter
Outer Diameter8 Millimeter
Length60 Millimeter
Outer Diameter8 Millimeter
Length60 Millimeter
Outer Diameter8 Millimeter
Length60 Millimeter
Outer Diameter8 Millimeter
Length60 Millimeter
Outer Diameter8 Millimeter
Length60 Millimeter
Outer Diameter8 Millimeter
Length60 Millimeter
Outer Diameter8 Millimeter
Length60 Millimeter
Outer Diameter8 Millimeter
Length60 Millimeter
Outer Diameter8 Millimeter
Length60 Millimeter
Outer Diameter8 Millimeter
Length60 Millimeter
Outer Diameter8 Millimeter
Length60 Millimeter
Outer Diameter8 Millimeter
Length60 Millimeter
Outer Diameter8 Millimeter
Length60 Millimeter
Outer Diameter8 Millimeter
Length60 Millimeter
Outer Diameter8 Millimeter
Length60 Millimeter
Outer Diameter8 Millimeter
Length60 Millimeter
Outer Diameter8 Millimeter
Length60 Millimeter
Outer Diameter8 Millimeter
Length60 Millimeter
Outer Diameter8 Millimeter
Length60 Millimeter
Outer Diameter8 Millimeter
Length60 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100810097803084 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OURSacroiliac Joint Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810097803084]

Moist Heat or Steam Sterilization


[00810097803084]

Moist Heat or Steam Sterilization


[00810097803084]

Moist Heat or Steam Sterilization


[00810097803084]

Moist Heat or Steam Sterilization


[00810097803084]

Moist Heat or Steam Sterilization


[00810097803084]

Moist Heat or Steam Sterilization


[00810097803084]

Moist Heat or Steam Sterilization


[00810097803084]

Moist Heat or Steam Sterilization


[00810097803084]

Moist Heat or Steam Sterilization


[00810097803084]

Moist Heat or Steam Sterilization


[00810097803084]

Moist Heat or Steam Sterilization


[00810097803084]

Moist Heat or Steam Sterilization


[00810097803084]

Moist Heat or Steam Sterilization


[00810097803084]

Moist Heat or Steam Sterilization


[00810097803084]

Moist Heat or Steam Sterilization


[00810097803084]

Moist Heat or Steam Sterilization


[00810097803084]

Moist Heat or Steam Sterilization


[00810097803084]

Moist Heat or Steam Sterilization


[00810097803084]

Moist Heat or Steam Sterilization


[00810097803084]

Moist Heat or Steam Sterilization


[00810097803084]

Moist Heat or Steam Sterilization


[00810097803084]

Moist Heat or Steam Sterilization


[00810097803084]

Moist Heat or Steam Sterilization


[00810097803084]

Moist Heat or Steam Sterilization


[00810097803084]

Moist Heat or Steam Sterilization


[00810097803084]

Moist Heat or Steam Sterilization


[00810097803084]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2025-05-19
Device Publish Date2024-06-19

Devices Manufactured by Osteocentric Technologies, Inc.

00810074307536 - 6.0 x 55mm Bone Screw Fastener ST2025-10-06 6.0 x 55mm Bone Screw Fastener ST
00810074307543 - 6.0 x 60mm Bone Screw Fastener ST2025-10-06 6.0 x 60mm Bone Screw Fastener ST
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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