Ø7.0 x 160mm CANNULATED FULL THREAD SCREW 370-5160-001

GUDID 00816950026621

Ø7.0 x 160mm CANNULATED FULL THREAD SCREW

Osteocentric Technologies, Inc.

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID00816950026621
NIH Device Record Key0ea85765-746d-465b-838a-cacda2d157ab
Commercial Distribution StatusIn Commercial Distribution
Brand NameØ7.0 x 160mm CANNULATED FULL THREAD SCREW
Version Model Number370-5160-001
Catalog Number370-5160-001
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
Emailinfo@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

Length160 Millimeter
Length160 Millimeter
Length160 Millimeter
Length160 Millimeter
Length160 Millimeter
Length160 Millimeter
Length160 Millimeter
Length160 Millimeter
Length160 Millimeter
Length160 Millimeter
Length160 Millimeter
Length160 Millimeter
Length160 Millimeter
Length160 Millimeter
Length160 Millimeter
Length160 Millimeter
Length160 Millimeter
Length160 Millimeter
Length160 Millimeter
Length160 Millimeter
Length160 Millimeter
Length160 Millimeter
Length160 Millimeter
Length160 Millimeter
Length160 Millimeter
Length160 Millimeter
Length160 Millimeter
Length160 Millimeter
Length160 Millimeter
Length160 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100816950026621 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816950026621]

Moist Heat or Steam Sterilization

[00816950026621]

Moist Heat or Steam Sterilization

[00816950026621]

Moist Heat or Steam Sterilization

[00816950026621]

Moist Heat or Steam Sterilization

[00816950026621]

Moist Heat or Steam Sterilization

[00816950026621]

Moist Heat or Steam Sterilization

[00816950026621]

Moist Heat or Steam Sterilization

[00816950026621]

Moist Heat or Steam Sterilization

[00816950026621]

Moist Heat or Steam Sterilization

[00816950026621]

Moist Heat or Steam Sterilization

[00816950026621]

Moist Heat or Steam Sterilization

[00816950026621]

Moist Heat or Steam Sterilization

[00816950026621]

Moist Heat or Steam Sterilization

[00816950026621]

Moist Heat or Steam Sterilization

[00816950026621]

Moist Heat or Steam Sterilization

[00816950026621]

Moist Heat or Steam Sterilization

[00816950026621]

Moist Heat or Steam Sterilization

[00816950026621]

Moist Heat or Steam Sterilization

[00816950026621]

Moist Heat or Steam Sterilization

[00816950026621]

Moist Heat or Steam Sterilization

[00816950026621]

Moist Heat or Steam Sterilization

[00816950026621]

Moist Heat or Steam Sterilization

[00816950026621]

Moist Heat or Steam Sterilization

[00816950026621]

Moist Heat or Steam Sterilization

[00816950026621]

Moist Heat or Steam Sterilization

[00816950026621]

Moist Heat or Steam Sterilization

[00816950026621]

Moist Heat or Steam Sterilization

[00816950026621]

Moist Heat or Steam Sterilization

[00816950026621]

Moist Heat or Steam Sterilization

[00816950026621]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-02-19
Device Publish Date2020-04-21

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00816950029530 - Large Depth Gauge 125mm2025-05-23 Large Depth Gauge 125mm
00810074309219 - POST-LAT DISTAL FIBULA PLATE 2H L2025-05-19 POST-LAT DISTAL FIBULA PLATE 2H L
00810074309226 - POST-LAT DISTAL FIBULA PLATE 2H R2025-05-19 POST-LAT DISTAL FIBULA PLATE 2H R
00810074309233 - POST-LAT DISTAL FIBULA PLATE 4H L2025-05-19 POST-LAT DISTAL FIBULA PLATE 4H L
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