Klassic Tibial Insert, PS-Post, Std Poly

GUDID 00814703015885

Tibial Insert, PS-Post, Std Poly, Size 2, 12mm

TOTAL JOINT ORTHOPEDICS, INC.

Posterior-stabilized total knee prosthesis

• Primary Device ID: 00814703015885
• NIH Device Record Key: 0c46e552-8645-416e-a482-3c26cb0c3e92
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Klassic Tibial Insert, PS-Post, Std Poly
• Version Model Number: 5304.02.012
• Company DUNS: 078416717
• Company Name: TOTAL JOINT ORTHOPEDICS, INC.
• 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

Customer Support Contacts

• Phone: +1(801)486-6070
• Email: udi@tjoinc.com

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814703015885 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183596

FDA Product Code

• MBH: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[00814703015885]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-24
• Device Publish Date: 2019-04-16

On-Brand Devices [Klassic Tibial Insert, PS-Post, Std Poly ]

• 00814703016196: Tibial Insert, PS-Post, Std Poly, Size 6, 16mm
• 00814703016189: Tibial Insert, PS-Post, Std Poly, Size 6, 14mm
• 00814703016172: Tibial Insert, PS-Post, Std Poly, Size 6, 13mm
• 00814703016165: Tibial Insert, PS-Post, Std Poly, Size 6, 12mm
• 00814703016158: Tibial Insert, PS-Post, Std Poly, Size 6, 11mm
• 00814703016141: Tibial Insert, PS-Post, Std Poly, Size 6, 10mm
• 00814703016127: Tibial Insert, PS-Post, Std Poly, Size 5, 16mm
• 00814703016110: Tibial Insert, PS-Post, Std Poly, Size 5, 14mm
• 00814703016103: Tibial Insert, PS-Post, Std Poly, Size 5, 13mm
• 00814703016097: Tibial Insert, PS-Post, Std Poly, Size 5, 12mm
• 00814703016080: Tibial Insert, PS-Post, Std Poly, Size 5, 11mm
• 00814703016073: Tibial Insert, PS-Post, Std Poly, Size 5, 10mm
• 00814703016059: Tibial Insert, PS-Post, Std Poly, Size 4, 16mm
• 00814703016042: Tibial Insert, PS-Post, Std Poly, Size 4, 14mm
• 00814703016035: Tibial Insert, PS-Post, Std Poly, Size 4, 13mm
• 00814703016028: Tibial Insert, PS-Post, Std Poly, Size 4, 12mm
• 00814703016011: Tibial Insert, PS-Post, Std Poly, Size 4, 11mm
• 00814703016004: Tibial Insert, PS-Post, Std Poly, Size 4, 10mm
• 00814703015984: Tibial Insert, PS-Post, Std Poly, Size 3, 16mm
• 00814703015977: Tibial Insert, PS-Post, Std Poly, Size 3, 14mm
• 00814703015960: Tibial Insert, PS-Post, Std Poly, Size 3, 13mm
• 00814703015953: Tibial Insert, PS-Post, Std Poly, Size 3, 12mm
• 00814703015946: Tibial Insert, PS-Post, Std Poly, Size 3, 11mm
• 00814703015939: Tibial Insert, PS-Post, Std Poly, Size 3, 10mm
• 00814703015915: Tibial Insert, PS-Post, Std Poly, Size 2, 16mm
• 00814703015908: Tibial Insert, PS-Post, Std Poly, Size 2, 14mm
• 00814703015892: Tibial Insert, PS-Post, Std Poly, Size 2, 13mm
• 00814703015885: Tibial Insert, PS-Post, Std Poly, Size 2, 12mm
• 00814703015878: Tibial Insert, PS-Post, Std Poly, Size 2, 11mm
• 00814703015861: Tibial Insert, PS-Post, Std Poly, Size 2, 10mm
• 00814703015847: Tibial Insert, PS-Post, Std Poly, Size 1, 16mm
• 00814703015830: Tibial Insert, PS-Post, Std Poly, Size 1, 14mm
• 00814703015823: Tibial Insert, PS-Post, Std Poly, Size 1, 13mm
• 00814703015816: Tibial Insert, PS-Post, Std Poly, Size 1, 12mm
• 00814703015809: Tibial Insert, PS-Post, Std Poly, Size 1, 11mm
• 00814703015793: Tibial Insert, PS-Post, Std Poly, Size 1, 10mm
• 00814703019166: Tibial Insert, PS-Post, Std Poly, Size 6, 24mm
• 00814703019159: Tibial Insert, PS-Post, Std Poly, Size 6, 21mm
• 00814703019142: Tibial Insert, PS-Post, Std Poly, Size 5, 24mm
• 00814703019135: Tibial Insert, PS-Post, Std Poly, Size 5, 21mm
• 00814703019128: Tibial Insert, PS-Post, Std Poly, Size 4, 24mm
• 00814703019111: Tibial Insert, PS-Post, Std Poly, Size 4, 21mm
• 00814703019104: Tibial Insert, PS-Post, Std Poly, Size 3, 24mm
• 00814703019098: Tibial Insert, PS-Post, Std Poly, Size 3, 21mm
• 00814703019081: Tibial Insert, PS-Post, Std Poly, Size 2, 24mm
• 00814703019074: Tibial Insert, PS-Post, Std Poly, Size 2, 21mm
• 00814703019067: Tibial Insert, PS-Post, Std Poly, Size 1, 24mm
• 00814703019050: Tibial Insert, PS-Post, Std Poly, Size 1, 21mm
• 00814703016202: Tibial Insert, PS-Post, Std Poly, Size 6, 18mm
• 00814703016134: Tibial Insert, PS-Post, Std Poly, Size 5, 18mm