My Spine Low Profile Placement Guides

GUDID 07630030877483

MySpine LP vertebra T04

Medacta International SA

Orthopaedic prosthesis implantation instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use

Primary Device ID	07630030877483
NIH Device Record Key	5026b88c-4474-48c6-9ab4-d4137e043b88
Commercial Distribution Status	In Commercial Distribution
Brand Name	My Spine Low Profile Placement Guides
Version Model Number	7.0404
Company DUNS	488227125
Company Name	Medacta International SA
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	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630030877483 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K153273

FDA Product Code

MNI	Orthosis, Spinal Pedicle Fixation

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[07630030877483]

Moist Heat or Steam Sterilization

[07630030877483]

Moist Heat or Steam Sterilization

[07630030877483]

Moist Heat or Steam Sterilization

[07630030877483]

Moist Heat or Steam Sterilization

[07630030877483]

Moist Heat or Steam Sterilization

[07630030877483]

Moist Heat or Steam Sterilization

[07630030877483]

Moist Heat or Steam Sterilization

[07630030877483]

Moist Heat or Steam Sterilization

[07630030877483]

Moist Heat or Steam Sterilization

[07630030877483]

Moist Heat or Steam Sterilization

[07630030877483]

Moist Heat or Steam Sterilization

[07630030877483]

Moist Heat or Steam Sterilization

[07630030877483]

Moist Heat or Steam Sterilization

[07630030877483]

Moist Heat or Steam Sterilization

[07630030877483]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2019-02-07
Device Publish Date	2016-08-31

On-Brand Devices [My Spine Low Profile Placement Guides]

07630030878091	MySpine LP guide L05 STERILE
07630030878084	MySpine LP guide L05
07630030878077	MySpine LP guide L04 STERILE
07630030878060	MySpine LP guide L04
07630030878053	MySpine LP guide L03 STERILE
07630030878046	MySpine LP guide L03
07630030878039	MySpine LP guide L02 STERILE
07630030878022	MySpine LP guide L02
07630030878015	MySpine LP guide L01 STERILE
07630030878008	MySpine LP guide L01
07630030877995	MySpine LP guide T12 STERILE
07630030877988	MySpine LP guide T12
07630030877971	MySpine LP guide T11 STERILE
07630030877964	MySpine LP guide T11
07630030877957	MySpine LP guide T10 STERILE
07630030877940	MySpine LP guide T10
07630030877933	MySpine LP guide T09 STERILE
07630030877926	MySpine LP guide T09
07630030877919	MySpine LP guide T08 STERILE
07630030877902	MySpine LP guide T08
07630030877896	MySpine LP guide T07 STERILE
07630030877889	MySpine LP guide T07
07630030877872	MySpine LP guide T06 STERILE
07630030877865	MySpine LP guide T06
07630030877858	MySpine LP guide T05 STERILE
07630030877841	MySpine LP guide T05
07630030877834	MySpine LP guide T04 STERILE
07630030877827	MySpine LP guide T04
07630030877810	MySpine LP guide T03 STERILE
07630030877803	MySpine LP guide T03
07630030877797	MySpine LP guide T02 STERILE
07630030877780	MySpine LP guide T02
07630030877773	MySpine LP guide T01 STERILE
07630030877766	MySpine LP guide T01
07630030877759	MySpine LP vertebra L05 STERILE
07630030877742	MySpine LP vertebra L05
07630030877735	MySpine LP vertebra L04 STERILE
07630030877728	MySpine LP vertebra L04
07630030877711	MySpine LP vertebra L03 STERILE
07630030877704	MySpine LP vertebra L03
07630030877698	MySpine LP vertebra L02 STERILE
07630030877681	MySpine LP vertebra L02
07630030877674	MySpine LP vertebra L01 STERILE
07630030877667	MySpine LP vertebra L01
07630030877650	MySpine LP vertebra T12 STERILE
07630030877643	MySpine LP vertebra T12
07630030877636	MySpine LP vertebra T11 STERILE
07630030877629	MySpine LP vertebra T11
07630030877612	MySpine LP vertebra T10 STERILE
07630030877605	MySpine LP vertebra T10

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