36mm, 2.7mm Cortical Screw, Self-Tapping 327-1036

GUDID 00816950020797

36mm, 2.7mm Cortical Screw, Self-Tapping

Osteocentric Technologies, Inc.

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID00816950020797
NIH Device Record Keyda1be660-cde4-4e84-a420-cd8cd59039a7
Commercial Distribution StatusIn Commercial Distribution
Brand Name36mm, 2.7mm Cortical Screw, Self-Tapping
Version Model Number327-1036
Catalog Number327-1036
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 Batchfalse
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
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com
Phone1 800 969 0639
Emailinfo@osteocentric.com

Device Dimensions

Outer Diameter2.7 Millimeter
Length36 Millimeter
Outer Diameter2.7 Millimeter
Length36 Millimeter
Outer Diameter2.7 Millimeter
Length36 Millimeter
Outer Diameter2.7 Millimeter
Length36 Millimeter
Outer Diameter2.7 Millimeter
Length36 Millimeter
Outer Diameter2.7 Millimeter
Length36 Millimeter
Outer Diameter2.7 Millimeter
Length36 Millimeter
Outer Diameter2.7 Millimeter
Length36 Millimeter
Outer Diameter2.7 Millimeter
Length36 Millimeter
Outer Diameter2.7 Millimeter
Length36 Millimeter
Outer Diameter2.7 Millimeter
Length36 Millimeter
Outer Diameter2.7 Millimeter
Length36 Millimeter
Outer Diameter2.7 Millimeter
Length36 Millimeter
Outer Diameter2.7 Millimeter
Length36 Millimeter
Outer Diameter2.7 Millimeter
Length36 Millimeter
Outer Diameter2.7 Millimeter
Length36 Millimeter
Outer Diameter2.7 Millimeter
Length36 Millimeter
Outer Diameter2.7 Millimeter
Length36 Millimeter
Outer Diameter2.7 Millimeter
Length36 Millimeter
Outer Diameter2.7 Millimeter
Length36 Millimeter
Outer Diameter2.7 Millimeter
Length36 Millimeter
Outer Diameter2.7 Millimeter
Length36 Millimeter
Outer Diameter2.7 Millimeter
Length36 Millimeter
Outer Diameter2.7 Millimeter
Length36 Millimeter
Outer Diameter2.7 Millimeter
Length36 Millimeter
Outer Diameter2.7 Millimeter
Length36 Millimeter
Outer Diameter2.7 Millimeter
Length36 Millimeter
Outer Diameter2.7 Millimeter
Length36 Millimeter
Outer Diameter2.7 Millimeter
Length36 Millimeter
Outer Diameter2.7 Millimeter
Length36 Millimeter
Outer Diameter2.7 Millimeter
Length36 Millimeter
Outer Diameter2.7 Millimeter
Length36 Millimeter
Outer Diameter2.7 Millimeter
Length36 Millimeter
Outer Diameter2.7 Millimeter
Length36 Millimeter
Outer Diameter2.7 Millimeter
Length36 Millimeter
Outer Diameter2.7 Millimeter
Length36 Millimeter
Outer Diameter2.7 Millimeter
Length36 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100816950020797 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816950020797]

Moist Heat or Steam Sterilization


[00816950020797]

Moist Heat or Steam Sterilization


[00816950020797]

Moist Heat or Steam Sterilization


[00816950020797]

Moist Heat or Steam Sterilization


[00816950020797]

Moist Heat or Steam Sterilization


[00816950020797]

Moist Heat or Steam Sterilization


[00816950020797]

Moist Heat or Steam Sterilization


[00816950020797]

Moist Heat or Steam Sterilization


[00816950020797]

Moist Heat or Steam Sterilization


[00816950020797]

Moist Heat or Steam Sterilization


[00816950020797]

Moist Heat or Steam Sterilization


[00816950020797]

Moist Heat or Steam Sterilization


[00816950020797]

Moist Heat or Steam Sterilization


[00816950020797]

Moist Heat or Steam Sterilization


[00816950020797]

Moist Heat or Steam Sterilization


[00816950020797]

Moist Heat or Steam Sterilization


[00816950020797]

Moist Heat or Steam Sterilization


[00816950020797]

Moist Heat or Steam Sterilization


[00816950020797]

Moist Heat or Steam Sterilization


[00816950020797]

Moist Heat or Steam Sterilization


[00816950020797]

Moist Heat or Steam Sterilization


[00816950020797]

Moist Heat or Steam Sterilization


[00816950020797]

Moist Heat or Steam Sterilization


[00816950020797]

Moist Heat or Steam Sterilization


[00816950020797]

Moist Heat or Steam Sterilization


[00816950020797]

Moist Heat or Steam Sterilization


[00816950020797]

Moist Heat or Steam Sterilization


[00816950020797]

Moist Heat or Steam Sterilization


[00816950020797]

Moist Heat or Steam Sterilization


[00816950020797]

Moist Heat or Steam Sterilization


[00816950020797]

Moist Heat or Steam Sterilization


[00816950020797]

Moist Heat or Steam Sterilization


[00816950020797]

Moist Heat or Steam Sterilization


[00816950020797]

Moist Heat or Steam Sterilization


[00816950020797]

Moist Heat or Steam Sterilization


[00816950020797]

Moist Heat or Steam Sterilization


[00816950020797]

Moist Heat or Steam Sterilization


[00816950020797]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2024-02-19
Device Publish Date2020-06-17

Devices Manufactured by Osteocentric Technologies, Inc.

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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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