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.

00810074306416 - 7.0mm Nut2025-07-02 7.0mm Nut
00810074306423 - 8.0mm Nut2025-07-02 8.0mm Nut
00816950025518 - 3.3mm Locking Screw Fastener ST 24mm2025-07-02 3.3mm Locking Screw Fastener ST 24mm
00816950025525 - 3.3mm Locking Screw Fastener ST 26mm2025-07-02 3.3mm Locking Screw Fastener ST 26mm
00816950025532 - 3.3mm Locking Screw Fastener ST 28mm2025-07-02 3.3mm Locking Screw Fastener ST 28mm
00816950025549 - 3.3mm Locking Screw Fastener ST 30mm2025-07-02 3.3mm Locking Screw Fastener ST 30mm
00816950025556 - 3.3mm Locking Screw Fastener ST 32mm2025-07-02 3.3mm Locking Screw Fastener ST 32mm
00816950025563 - 3.3mm Locking Screw Fastener ST 34mm2025-07-02 3.3mm Locking Screw Fastener ST 34mm
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.