8.0 X 125mm Cann Screw Fastener Full Thd 380-5125-001

GUDID 00810074306645

8.0 X 125mm Cann Screw Fastener Full Thd

Osteocentric Technologies, Inc.

Orthopaedic bone screw (non-sliding)
Primary Device ID00810074306645
NIH Device Record Keyf101d299-6d80-4d32-a4a7-cbb78cae6009
Commercial Distribution StatusIn Commercial Distribution
Brand Name8.0 X 125mm Cann Screw Fastener Full Thd
Version Model Number380-5125-001
Catalog Number380-5125-001
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

Phone1800-969-0639
Emailquality@osteocentric.com
Phone1800-969-0639
Emailquality@osteocentric.com
Phone1800-969-0639
Emailquality@osteocentric.com
Phone1800-969-0639
Emailquality@osteocentric.com
Phone1800-969-0639
Emailquality@osteocentric.com
Phone1800-969-0639
Emailquality@osteocentric.com
Phone1800-969-0639
Emailquality@osteocentric.com
Phone1800-969-0639
Emailquality@osteocentric.com
Phone1800-969-0639
Emailquality@osteocentric.com
Phone1800-969-0639
Emailquality@osteocentric.com
Phone1800-969-0639
Emailquality@osteocentric.com
Phone1800-969-0639
Emailquality@osteocentric.com
Phone1800-969-0639
Emailquality@osteocentric.com
Phone1800-969-0639
Emailquality@osteocentric.com
Phone1800-969-0639
Emailquality@osteocentric.com
Phone1800-969-0639
Emailquality@osteocentric.com
Phone1800-969-0639
Emailquality@osteocentric.com
Phone1800-969-0639
Emailquality@osteocentric.com
Phone1800-969-0639
Emailquality@osteocentric.com
Phone1800-969-0639
Emailquality@osteocentric.com
Phone1800-969-0639
Emailquality@osteocentric.com
Phone1800-969-0639
Emailquality@osteocentric.com
Phone1800-969-0639
Emailquality@osteocentric.com
Phone1800-969-0639
Emailquality@osteocentric.com
Phone1800-969-0639
Emailquality@osteocentric.com
Phone1800-969-0639
Emailquality@osteocentric.com
Phone1800-969-0639
Emailquality@osteocentric.com
Phone1800-969-0639
Emailquality@osteocentric.com
Phone1800-969-0639
Emailquality@osteocentric.com
Phone1800-969-0639
Emailquality@osteocentric.com
Phone1800-969-0639
Emailquality@osteocentric.com
Phone1800-969-0639
Emailquality@osteocentric.com
Phone1800-969-0639
Emailquality@osteocentric.com
Phone1800-969-0639
Emailquality@osteocentric.com
Phone1800-969-0639
Emailquality@osteocentric.com
Phone1800-969-0639
Emailquality@osteocentric.com
Phone1800-969-0639
Emailquality@osteocentric.com
Phone1800-969-0639
Emailquality@osteocentric.com
Phone1800-969-0639
Emailquality@osteocentric.com
Phone1800-969-0639
Emailquality@osteocentric.com
Phone1800-969-0639
Emailquality@osteocentric.com
Phone1800-969-0639
Emailquality@osteocentric.com
Phone1800-969-0639
Emailquality@osteocentric.com

Device Dimensions

Outer Diameter8 Millimeter
Length125 Millimeter
Outer Diameter8 Millimeter
Length125 Millimeter
Outer Diameter8 Millimeter
Length125 Millimeter
Outer Diameter8 Millimeter
Length125 Millimeter
Outer Diameter8 Millimeter
Length125 Millimeter
Outer Diameter8 Millimeter
Length125 Millimeter
Outer Diameter8 Millimeter
Length125 Millimeter
Outer Diameter8 Millimeter
Length125 Millimeter
Outer Diameter8 Millimeter
Length125 Millimeter
Outer Diameter8 Millimeter
Length125 Millimeter
Outer Diameter8 Millimeter
Length125 Millimeter
Outer Diameter8 Millimeter
Length125 Millimeter
Outer Diameter8 Millimeter
Length125 Millimeter
Outer Diameter8 Millimeter
Length125 Millimeter
Outer Diameter8 Millimeter
Length125 Millimeter
Outer Diameter8 Millimeter
Length125 Millimeter
Outer Diameter8 Millimeter
Length125 Millimeter
Outer Diameter8 Millimeter
Length125 Millimeter
Outer Diameter8 Millimeter
Length125 Millimeter
Outer Diameter8 Millimeter
Length125 Millimeter
Outer Diameter8 Millimeter
Length125 Millimeter
Outer Diameter8 Millimeter
Length125 Millimeter
Outer Diameter8 Millimeter
Length125 Millimeter
Outer Diameter8 Millimeter
Length125 Millimeter
Outer Diameter8 Millimeter
Length125 Millimeter
Outer Diameter8 Millimeter
Length125 Millimeter
Outer Diameter8 Millimeter
Length125 Millimeter
Outer Diameter8 Millimeter
Length125 Millimeter
Outer Diameter8 Millimeter
Length125 Millimeter
Outer Diameter8 Millimeter
Length125 Millimeter
Outer Diameter8 Millimeter
Length125 Millimeter
Outer Diameter8 Millimeter
Length125 Millimeter
Outer Diameter8 Millimeter
Length125 Millimeter
Outer Diameter8 Millimeter
Length125 Millimeter
Outer Diameter8 Millimeter
Length125 Millimeter
Outer Diameter8 Millimeter
Length125 Millimeter
Outer Diameter8 Millimeter
Length125 Millimeter
Outer Diameter8 Millimeter
Length125 Millimeter
Outer Diameter8 Millimeter
Length125 Millimeter
Outer Diameter8 Millimeter
Length125 Millimeter
Outer Diameter8 Millimeter
Length125 Millimeter
Outer Diameter8 Millimeter
Length125 Millimeter
Outer Diameter8 Millimeter
Length125 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100810074306645 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810074306645]

Moist Heat or Steam Sterilization

[00810074306645]

Moist Heat or Steam Sterilization

[00810074306645]

Moist Heat or Steam Sterilization

[00810074306645]

Moist Heat or Steam Sterilization

[00810074306645]

Moist Heat or Steam Sterilization

[00810074306645]

Moist Heat or Steam Sterilization

[00810074306645]

Moist Heat or Steam Sterilization

[00810074306645]

Moist Heat or Steam Sterilization

[00810074306645]

Moist Heat or Steam Sterilization

[00810074306645]

Moist Heat or Steam Sterilization

[00810074306645]

Moist Heat or Steam Sterilization

[00810074306645]

Moist Heat or Steam Sterilization

[00810074306645]

Moist Heat or Steam Sterilization

[00810074306645]

Moist Heat or Steam Sterilization

[00810074306645]

Moist Heat or Steam Sterilization

[00810074306645]

Moist Heat or Steam Sterilization

[00810074306645]

Moist Heat or Steam Sterilization

[00810074306645]

Moist Heat or Steam Sterilization

[00810074306645]

Moist Heat or Steam Sterilization

[00810074306645]

Moist Heat or Steam Sterilization

[00810074306645]

Moist Heat or Steam Sterilization

[00810074306645]

Moist Heat or Steam Sterilization

[00810074306645]

Moist Heat or Steam Sterilization

[00810074306645]

Moist Heat or Steam Sterilization

[00810074306645]

Moist Heat or Steam Sterilization

[00810074306645]

Moist Heat or Steam Sterilization

[00810074306645]

Moist Heat or Steam Sterilization

[00810074306645]

Moist Heat or Steam Sterilization

[00810074306645]

Moist Heat or Steam Sterilization

[00810074306645]

Moist Heat or Steam Sterilization

[00810074306645]

Moist Heat or Steam Sterilization

[00810074306645]

Moist Heat or Steam Sterilization

[00810074306645]

Moist Heat or Steam Sterilization

[00810074306645]

Moist Heat or Steam Sterilization

[00810074306645]

Moist Heat or Steam Sterilization

[00810074306645]

Moist Heat or Steam Sterilization

[00810074306645]

Moist Heat or Steam Sterilization

[00810074306645]

Moist Heat or Steam Sterilization

[00810074306645]

Moist Heat or Steam Sterilization

[00810074306645]

Moist Heat or Steam Sterilization

[00810074306645]

Moist Heat or Steam Sterilization

[00810074306645]

Moist Heat or Steam Sterilization

[00810074306645]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-06
Device Publish Date2023-09-28

Devices Manufactured by Osteocentric Technologies, Inc.

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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
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