TIBIAL REVISON PLATFORM M-3212-4305-R

GUDID B565M32124305R1

TIBIAL AUGMENT TRIAL SZ 3 5MM RIGHT

CPM MEDICAL CONSULTANTS, LLC

Posterior-stabilized total knee prosthesis

Primary Device ID	B565M32124305R1
NIH Device Record Key	eac0599d-f28b-42ab-b000-93ab3f3ef0d5
Commercial Distribution Status	In Commercial Distribution
Brand Name	TIBIAL REVISON PLATFORM
Version Model Number	REV C
Catalog Number	M-3212-4305-R
Company DUNS	017138000
Company Name	CPM MEDICAL CONSULTANTS, LLC
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	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

Customer Support Contacts

Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B565M32124305R1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K210695

FDA Product Code

JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[B565M32124305R1]

Moist Heat or Steam Sterilization

[B565M32124305R1]

Moist Heat or Steam Sterilization

[B565M32124305R1]

Moist Heat or Steam Sterilization

[B565M32124305R1]

Moist Heat or Steam Sterilization

[B565M32124305R1]

Moist Heat or Steam Sterilization

[B565M32124305R1]

Moist Heat or Steam Sterilization

[B565M32124305R1]

Moist Heat or Steam Sterilization

[B565M32124305R1]

Moist Heat or Steam Sterilization

[B565M32124305R1]

Moist Heat or Steam Sterilization

[B565M32124305R1]

Moist Heat or Steam Sterilization

[B565M32124305R1]

Moist Heat or Steam Sterilization

[B565M32124305R1]

Moist Heat or Steam Sterilization

[B565M32124305R1]

Moist Heat or Steam Sterilization

[B565M32124305R1]

Moist Heat or Steam Sterilization

[B565M32124305R1]

Moist Heat or Steam Sterilization

[B565M32124305R1]

Moist Heat or Steam Sterilization

[B565M32124305R1]

Moist Heat or Steam Sterilization

[B565M32124305R1]

Moist Heat or Steam Sterilization

[B565M32124305R1]

Moist Heat or Steam Sterilization

[B565M32124305R1]

Moist Heat or Steam Sterilization

[B565M32124305R1]

Moist Heat or Steam Sterilization

[B565M32124305R1]

Moist Heat or Steam Sterilization

[B565M32124305R1]

Moist Heat or Steam Sterilization

[B565M32124305R1]

Moist Heat or Steam Sterilization

[B565M32124305R1]

Moist Heat or Steam Sterilization

[B565M32124305R1]

Moist Heat or Steam Sterilization

[B565M32124305R1]

Moist Heat or Steam Sterilization

[B565M32124305R1]

Moist Heat or Steam Sterilization

[B565M32124305R1]

Moist Heat or Steam Sterilization

[B565M32124305R1]

Moist Heat or Steam Sterilization

[B565M32124305R1]

Moist Heat or Steam Sterilization

[B565M32124305R1]

Moist Heat or Steam Sterilization

[B565M32124305R1]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2022-04-04
Device Publish Date	2022-03-25

On-Brand Devices [TIBIAL REVISON PLATFORM]

B565M32124605R1	TIBIAL AUGMENT TRIAL SZ 6 5MM RIGHT
B565M32124605L1	TIBIAL AUGMENT TRIAL SZ 6 5MM LEFT
B565M32124510R1	TIBIAL AUGMENT TRIAL SZ 5 10MM RIGHT
B565M32124505R1	TIBIAL AUGMENT TRIAL SZ 5 5MM RIGHT
B565M32124505L1	TIBIAL AUGMENT TRIAL SZ 5 5MM LEFT
B565M32124405R1	TIBIAL AUGMENT TRIAL SZ 4 5MM RIGHT
B565M32124405L1	TIBIAL AUGMENT TRIAL SZ 4 5MM LEFT
B565M32124305R1	TIBIAL AUGMENT TRIAL SZ 3 5MM RIGHT
B565M32124305L1	TIBIAL AUGMENT TRIAL SZ 3 5MM LEFT
B565M32124205R1	TIBIAL AUGMENT TRIAL SZ 2 5MM RIGHT
B565M32124205L1	TIBIAL AUGMENT TRIAL SZ 2 5MM LEFT
B565M32124105R1	TIBIAL AUGMENT TRIAL SZ 1 5MM RIGHT
B565M32124105L1	TIBIAL AUGMENT TRIAL SZ 1 5MM LEFT
B565M32124005R1	TIBIAL AUGMENT TRIAL SZ 0 5MM RIGHT
B565M32124005L1	TIBIAL AUGMENT TRIAL SZ 0 5MM LEFT

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