OsteoCentric 4.0 x 66mm LOCKING BONE SCREW FASTENER ST 340-6066

GUDID 00816950027611

4.0 x 66mm LOCKING BONE SCREW FASTENER, ST

SMV SCIENTIFIC LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID00816950027611
NIH Device Record Key5d336040-9ac7-43a2-b51a-1badd8ffaf70
Commercial Distribution StatusIn Commercial Distribution
Brand NameOsteoCentric 4.0 x 66mm LOCKING BONE SCREW FASTENER ST
Version Model Number340-6066
Catalog Number340-6066
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
Emailgudid@smvscientific.com
Phone1-800-969-0639
Emailgudid@smvscientific.com
Phone1-800-969-0639
Emailgudid@smvscientific.com
Phone1-800-969-0639
Emailgudid@smvscientific.com
Phone1-800-969-0639
Emailgudid@smvscientific.com
Phone1-800-969-0639
Emailgudid@smvscientific.com
Phone1-800-969-0639
Emailgudid@smvscientific.com
Phone1-800-969-0639
Emailgudid@smvscientific.com
Phone1-800-969-0639
Emailgudid@smvscientific.com
Phone1-800-969-0639
Emailgudid@smvscientific.com
Phone1-800-969-0639
Emailgudid@smvscientific.com
Phone1-800-969-0639
Emailgudid@smvscientific.com
Phone1-800-969-0639
Emailgudid@smvscientific.com
Phone1-800-969-0639
Emailgudid@smvscientific.com
Phone1-800-969-0639
Emailgudid@smvscientific.com
Phone1-800-969-0639
Emailgudid@smvscientific.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
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

Length66 Millimeter
Length66 Millimeter
Length66 Millimeter
Length66 Millimeter
Length66 Millimeter
Length66 Millimeter
Length66 Millimeter
Length66 Millimeter
Length66 Millimeter
Length66 Millimeter
Length66 Millimeter
Length66 Millimeter
Length66 Millimeter
Length66 Millimeter
Length66 Millimeter
Length66 Millimeter
Length66 Millimeter
Length66 Millimeter
Length66 Millimeter
Length66 Millimeter
Length66 Millimeter
Length66 Millimeter
Length66 Millimeter
Length66 Millimeter
Length66 Millimeter
Length66 Millimeter
Length66 Millimeter
Length66 Millimeter
Length66 Millimeter
Length66 Millimeter
Length66 Millimeter
Length66 Millimeter
Length66 Millimeter
Length66 Millimeter
Length66 Millimeter
Length66 Millimeter
Length66 Millimeter
Length66 Millimeter
Length66 Millimeter
Length66 Millimeter
Length66 Millimeter
Length66 Millimeter
Length66 Millimeter
Length66 Millimeter
Length66 Millimeter
Length66 Millimeter
Length66 Millimeter
Length66 Millimeter
Length66 Millimeter
Length66 Millimeter
Length66 Millimeter
Length66 Millimeter
Length66 Millimeter
Length66 Millimeter
Length66 Millimeter
Length66 Millimeter
Length66 Millimeter
Length66 Millimeter
Length66 Millimeter
Length66 Millimeter
Length66 Millimeter
Length66 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100816950027611 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


[00816950027611]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-05
Device Publish Date2020-09-25

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.