LOSPA TKR SYSTEM

GUDID 08800068953575

Tibial Insert Trial PS #03 T14

Corentec Co., Ltd

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Primary Device ID	08800068953575
NIH Device Record Key	fa7af234-7062-4931-9149-9acebda511b1
Commercial Distribution Status	In Commercial Distribution
Brand Name	LOSPA TKR SYSTEM
Version Model Number	KA.SPS.0314
Company DUNS	688739895
Company Name	Corentec Co., Ltd
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	false
Lot Batch	true
Serial Number	false
Manufacturing Date	true
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 Identifiers

Device Issuing Agency	Device ID
GS1	08800068953575 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K212034

FDA Product Code

Template

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[08800068953575]

Moist Heat or Steam Sterilization

[08800068953575]

Moist Heat or Steam Sterilization

[08800068953575]

Moist Heat or Steam Sterilization

[08800068953575]

Moist Heat or Steam Sterilization

[08800068953575]

Moist Heat or Steam Sterilization

[08800068953575]

Moist Heat or Steam Sterilization

[08800068953575]

Moist Heat or Steam Sterilization

[08800068953575]

Moist Heat or Steam Sterilization

[08800068953575]

Moist Heat or Steam Sterilization

[08800068953575]

Moist Heat or Steam Sterilization

[08800068953575]

Moist Heat or Steam Sterilization

[08800068953575]

Moist Heat or Steam Sterilization

[08800068953575]

Moist Heat or Steam Sterilization

[08800068953575]

Moist Heat or Steam Sterilization

[08800068953575]

Moist Heat or Steam Sterilization

[08800068953575]

Moist Heat or Steam Sterilization

[08800068953575]

Moist Heat or Steam Sterilization

[08800068953575]

Moist Heat or Steam Sterilization

[08800068953575]

Moist Heat or Steam Sterilization

[08800068953575]

Moist Heat or Steam Sterilization

[08800068953575]

Moist Heat or Steam Sterilization

[08800068953575]

Moist Heat or Steam Sterilization

[08800068953575]

Moist Heat or Steam Sterilization

[08800068953575]

Moist Heat or Steam Sterilization

[08800068953575]

Moist Heat or Steam Sterilization

[08800068953575]

Moist Heat or Steam Sterilization

[08800068953575]

Moist Heat or Steam Sterilization

[08800068953575]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2022-01-07
Device Publish Date	2021-12-30

On-Brand Devices [LOSPA TKR SYSTEM]

08800068950215	LOSPA Tibial Insert Trial CR #03 T08
08800068950161	Tibial Insert Trial CR #03 T10
08800068950772	Tibial Insert Trial CR #06 T24
08800068950765	Tibial Insert Trial CR #06 T22
08800068950758	Tibial Insert Trial CR #06 T20
08800068950741	Tibial Insert Trial CR #06 T18
08800068950734	Tibial Insert Trial CR #06 T16
08800068950727	Tibial Insert Trial CR #06 T14
08800068950710	Tibial Insert Trial CR #06 T12
08800068950703	Tibial Insert Trial CR #06 T10
08800068950697	Tibial Insert Trial CR #06 T08
08800068950680	Tibial Insert Trial CR #05 T18
08800068950673	Tibial Insert Trial CR #05 T16
08800068950666	Tibial Insert Trial CR #05 T14
08800068950659	Tibial Insert Trial CR #05 T08
08800068950642	Tibial Insert Trial CR #05 T24
08800068950635	Tibial Insert Trial CR #05 T22
08800068950628	Tibial Insert Trial CR #05 T20
08800068950611	Tibial Insert Trial CR #05 T12
08800068950604	Tibial Insert Trial CR #05 T10
08800068950574	Tibial Insert Trial CR #04 T18
08800068950567	Tibial Insert Trial CR #04 T16
08800068950550	Tibial Insert Trial CR #04 T14
08800068950543	Tibial Insert Trial CR #04 T08
08800068950536	Tibial Insert Trial CR #04 T24
08800068950529	Tibial Insert Trial CR #04 T22
08800068950512	Tibial Insert Trial CR #04 T20
08800068950505	Tibial Insert Trial CR #04 T12
08800068950499	Tibial Insert Trial CR #04 T10
08800068950246	Tibial Insert Trial CR #03 T18
08800068950239	Tibial Insert Trial CR #03 T16
08800068950222	Tibial Insert Trial CR #03 T14
08800068950208	Tibial Insert Trial CR #03 T24
08800068950192	Tibial Insert Trial CR #03 T22
08800068950185	Tibial Insert Trial CR #03 T20
08800068950178	Tibial Insert Trial CR #03 T12
08800068960450	Tibial Insert Trial CR #11 T22
08800068954909	Tibial Insert Trial PS #05 T10
08800068953889	Tibial Insert Trial PS #05 T18
08800068953872	Tibial Insert Trial PS #05 T16
08800068953865	Tibial Insert Trial PS #05 T14
08800068953858	Tibial Insert Trial PS #05 T08
08800068953827	Tibial Insert Trial PS #05 T20
08800068953810	Tibial Insert Trial PS #05 T12
08800068953629	Tibial Insert Trial PS #04 T18
08800068953612	Tibial Insert Trial PS #03 T18
08800068953605	Tibial Insert Trial PS #04 T16
08800068953599	Tibial Insert Trial PS #03 T16
08800068953582	Tibial Insert Trial PS #04 T14
08800068953575	Tibial Insert Trial PS #03 T14

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