GMK Hinge and Revision TiNbN coated

GUDID 07630971258426

TiNbN coated SC Peg - 12mm

Medacta International SA

Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert

• Primary Device ID: 07630971258426
• NIH Device Record Key: cf0e1a3e-fd70-4b0a-a6ae-cdb873be7331
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GMK Hinge and Revision TiNbN coated
• Version Model Number: 02.07.SCP12
• 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	07630971258426 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210010

FDA Product Code

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

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-12
• Device Publish Date: 2021-03-04

On-Brand Devices [GMK Hinge and Revision TiNbN coated]

• 07630971258549: GMK-HINGE Hinge Post Extension 26 mm -TiNbN coated
• 07630971258532: GMK-HINGE Hinge Post Extension 23 mm -TiNbN coated
• 07630971258525: GMK-HINGE Hinge Post Extension 20 mm -TiNbN coated
• 07630971258518: GMK-HINGE Hinge Post Extension 17 mm -TiNbN coated
• 07630971258501: GMK-HINGE Hinge Post Extension 14 mm -TiNbN coated
• 07630971258495: GMK-HINGE Hinge Post Extension 12 mm -TiNbN coated
• 07630971258488: GMK-HINGE Hinge Post Extension 10 mm -TiNbN coated
• 07630971258471: TiNbN coated SC Peg - 26mm
• 07630971258464: TiNbN coated SC Peg - 23mm
• 07630971258457: TiNbN coated SC Peg - 20mm
• 07630971258440: TiNbN coated SC Peg - 17mm
• 07630971258433: TiNbN coated SC Peg - 14mm
• 07630971258426: TiNbN coated SC Peg - 12mm
• 07630971258419: TiNbN coated SC Peg - 10mm
• 07630971258280: TiNbN coated Revision Tibial Tray size 6 Right
• 07630971258273: TiNbN coated Revision Tibial Tray size 6 Left
• 07630971258266: TiNbN coated Revision Tibial Tray size 5 Right
• 07630971258259: TiNbN coated Revision Tibial Tray size 5 Left
• 07630971258242: TiNbN coated Revision Tibial Tray size 4 Right
• 07630971258235: TiNbN coated Revision Tibial Tray size 4 Left
• 07630971258228: TiNbN coated Revision Tibial Tray size 3 Right
• 07630971258211: TiNbN coated Revision Tibial Tray size 3 Left
• 07630971258204: TiNbN coated Revision Tibial Tray size 2 Right
• 07630971258198: TiNbN coated Revision Tibial Tray size 2 Left
• 07630971258181: TiNbN coated Revision Tibial Tray size 1 Right
• 07630971258174: TiNbN coated Revision Tibial Tray size 1 Left
• 07630971258167: TiNbN coated Femur Revision STD # 6 R
• 07630971258150: TiNbN coated Femur Revision STD # 6 L
• 07630971258143: TiNbN coated Femur Revision STD # 5 R
• 07630971258136: TiNbN coated Femur Revision STD # 5 L
• 07630971258129: TiNbN coated Femur Revision STD # 4 R
• 07630971258112: TiNbN coated Femur Revision STD # 4 L
• 07630971258105: TiNbN coated Femur Revision STD # 3 R
• 07630971258099: TiNbN coated Femur Revision STD # 3 L
• 07630971258082: TiNbN coated Femur Revision STD # 2 R
• 07630971258075: TiNbN coated Femur Revision STD # 2 L
• 07630971258068: TiNbN coated Femur Revision STD # 1 R
• 07630971258051: TiNbN coated Femur Revision STD # 1 L
• 07630971258044: TiNbN coated Femur Revision PS # 6 R
• 07630971258037: TiNbN coated Femur Revision PS # 6 L
• 07630971258020: TiNbN coated Femur Revision PS # 5 R
• 07630971258013: TiNbN coated Femur Revision PS # 5 L
• 07630971258006: TiNbN coated Femur Revision PS # 4 R
• 07630971257993: TiNbN coated Femur Revision PS # 4 L
• 07630971257986: TiNbN coated Femur Revision PS # 3 R
• 07630971257979: TiNbN coated Femur Revision PS # 3 L
• 07630971257962: TiNbN coated Femur Revision PS # 2 R
• 07630971257955: TiNbN coated Femur Revision PS # 2 L
• 07630971257948: TiNbN coated Femur Revision PS # 1 R
• 07630971257931: TiNbN coated Femur Revision PS # 1 L