10 x 80mm SI Fusion Fastener Cann Sterile 202-10080-S

GUDID 00810097801417

10 x 80mm SI Fusion Fastener Cann Sterile

SMV SCIENTIFIC LLC

Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, sterile
Primary Device ID00810097801417
NIH Device Record Key025eb801-3dd2-4a7e-857c-7ec296d09833
Commercial Distribution StatusIn Commercial Distribution
Brand Name10 x 80mm SI Fusion Fastener Cann Sterile
Version Model Number202-10080-S
Catalog Number202-10080-S
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
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
Length80 Millimeter
Outer Diameter10 Millimeter
Length80 Millimeter
Outer Diameter10 Millimeter
Length80 Millimeter
Outer Diameter10 Millimeter
Length80 Millimeter
Outer Diameter10 Millimeter
Length80 Millimeter
Outer Diameter10 Millimeter
Length80 Millimeter
Outer Diameter10 Millimeter
Length80 Millimeter
Outer Diameter10 Millimeter
Length80 Millimeter
Outer Diameter10 Millimeter
Length80 Millimeter
Outer Diameter10 Millimeter
Length80 Millimeter
Outer Diameter10 Millimeter
Length80 Millimeter
Outer Diameter10 Millimeter
Length80 Millimeter
Outer Diameter10 Millimeter
Length80 Millimeter
Outer Diameter10 Millimeter
Length80 Millimeter
Outer Diameter10 Millimeter
Length80 Millimeter
Outer Diameter10 Millimeter
Length80 Millimeter
Outer Diameter10 Millimeter
Length80 Millimeter
Outer Diameter10 Millimeter
Length80 Millimeter
Outer Diameter10 Millimeter
Length80 Millimeter
Outer Diameter10 Millimeter
Length80 Millimeter
Outer Diameter10 Millimeter
Length80 Millimeter
Outer Diameter10 Millimeter
Length80 Millimeter
Outer Diameter10 Millimeter
Length80 Millimeter
Outer Diameter10 Millimeter
Length80 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100810097801417 [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 Date2022-08-25
Device Publish Date2022-08-17

Devices Manufactured by SMV SCIENTIFIC LLC

00810074300001 - 4.0 x 12mm Screw Super Fastener, ST2023-06-20 4.0 x 12mm Screw Super Fastener, ST
00810074300018 - 4.0 x 14mm Screw Super Fastener, ST2023-06-20 4.0 x 14mm Screw Super Fastener, ST
00810074300025 - 4.0 x 16mm Screw Super Fastener, ST2023-06-20 4.0 x 16mm Screw Super Fastener, ST
00810074300032 - 4.0 x 18mm Screw Super Fastener, ST2023-06-20 4.0 x 18mm Screw Super Fastener, ST
00810074300049 - 4.0 x 20mm Screw Super Fastener, ST2023-06-20 4.0 x 20mm Screw Super Fastener, ST
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

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.