Osteolock 5260-5-016

GUDID 07613327035643

3.5mm Hex Drive Head Cancellous Screw

Howmedica Osteonics Corp.

Orthopaedic bone screw, non-bioabsorbable, sterile

Primary Device ID	07613327035643
NIH Device Record Key	b43fb15b-c8ca-46a4-b7dd-02aa5a4d44a8
Commercial Distribution Status	In Commercial Distribution
Brand Name	Osteolock
Version Model Number	5260-5-016
Catalog Number	5260-5-016
Company DUNS	058311945
Company Name	Howmedica Osteonics Corp.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
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Length	16 Millimeter
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Length	16 Millimeter
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Length	16 Millimeter
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Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
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Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
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Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter
Device Size Text, specify	0
Length	16 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327035643 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K903362

FDA Product Code

JDI	Prosthesis, hip, semi-constrained, metal/polymer, cemented

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2015-09-24

On-Brand Devices [Osteolock]

07613327035759	3.5mm Hex Drive Head Cancellous Screw
07613327035742	3.5mm Hex Drive Head Cancellous Screw
07613327035735	3.5mm Hex Drive Head Cancellous Screw
07613327035728	3.5mm Hex Drive Head Cancellous Screw
07613327035711	3.5mm Hex Drive Head Cancellous Screw
07613327035704	3.5mm Hex Drive Head Cancellous Screw
07613327035698	3.5mm Hex Drive Head Cancellous Screw
07613327035681	3.5mm Hex Drive Head Cancellous Screw
07613327035674	3.5mm Hex Drive Head Cancellous Screw
07613327035667	3.5mm Hex Drive Head Cancellous Screw
07613327035650	3.5mm Hex Drive Head Cancellous Screw
07613327035643	3.5mm Hex Drive Head Cancellous Screw
07613327035636	3.5mm Hex Drive Head Cancellous Screw
07613327035629	3.5mm Hex Drive Head Cancellous Screw

Trademark Results [Osteolock]

Mark Image Registration \| Serial	Company Trademark Application Date
OSTEOLOCK 77518307 3793867 Dead/Cancelled	Bacterin International, Inc 2008-07-09