Ø7.0 x 115mm CANNULATED FULL THREAD SCREW 370-5115-001

GUDID 00816950026539

Ø7.0 x 115mm CANNULATED FULL THREAD SCREW

Osteocentric Technologies, Inc.

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID00816950026539
NIH Device Record Key79305926-d700-4b70-8e84-aeb39c8c0c7d
Commercial Distribution StatusIn Commercial Distribution
Brand NameØ7.0 x 115mm CANNULATED FULL THREAD SCREW
Version Model Number370-5115-001
Catalog Number370-5115-001
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

Device Dimensions

Length115 Millimeter
Length115 Millimeter
Length115 Millimeter
Length115 Millimeter
Length115 Millimeter
Length115 Millimeter
Length115 Millimeter
Length115 Millimeter
Length115 Millimeter
Length115 Millimeter
Length115 Millimeter
Length115 Millimeter
Length115 Millimeter
Length115 Millimeter
Length115 Millimeter
Length115 Millimeter
Length115 Millimeter
Length115 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100816950026539 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816950026539]

Moist Heat or Steam Sterilization

[00816950026539]

Moist Heat or Steam Sterilization

[00816950026539]

Moist Heat or Steam Sterilization

[00816950026539]

Moist Heat or Steam Sterilization

[00816950026539]

Moist Heat or Steam Sterilization

[00816950026539]

Moist Heat or Steam Sterilization

[00816950026539]

Moist Heat or Steam Sterilization

[00816950026539]

Moist Heat or Steam Sterilization

[00816950026539]

Moist Heat or Steam Sterilization

[00816950026539]

Moist Heat or Steam Sterilization

[00816950026539]

Moist Heat or Steam Sterilization

[00816950026539]

Moist Heat or Steam Sterilization

[00816950026539]

Moist Heat or Steam Sterilization

[00816950026539]

Moist Heat or Steam Sterilization

[00816950026539]

Moist Heat or Steam Sterilization

[00816950026539]

Moist Heat or Steam Sterilization

[00816950026539]

Moist Heat or Steam Sterilization

[00816950026539]

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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00810097803473 - PRIMARY DEPTH GAUGE2025-01-15 PRIMARY DEPTH GAUGE
00810074302364 - 120mm Locking Lateral Distal Fibula Plate Left2024-12-17 120mm Locking Lateral Distal Fibula Plate Left
00810074302371 - 140mm Locking Lateral Distal Fibula Plate Left2024-12-17 140mm Locking Lateral Distal Fibula Plate Left
00810074302388 - 120mm Locking Lateral Distal Fibula Plate Right2024-12-17 120mm Locking Lateral Distal Fibula Plate Right
00810074302395 - 140mm Locking Lateral Distal Fibula Plate Right2024-12-17 140mm Locking Lateral Distal Fibula Plate Right
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