ATTUNE 299966466

GUDID 10603295511342

ATTUNE MAKE TO ORDER AP MODIFIED CUT BLOCK SIZE 9

DEPUY ORTHOPAEDICS, INC.

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 10603295511342
• NIH Device Record Key: 4c368a13-7fc2-4298-91b3-986b89ced8d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ATTUNE
• Version Model Number: 2999-66-466
• Catalog Number: 299966466
• Company DUNS: 080506581
• Company Name: DEPUY ORTHOPAEDICS, 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: 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295511342 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140881

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: false

[10603295511342]

Moist Heat or Steam Sterilization

[10603295511342]

Moist Heat or Steam Sterilization

[10603295511342]

Moist Heat or Steam Sterilization

[10603295511342]

Moist Heat or Steam Sterilization

[10603295511342]

Moist Heat or Steam Sterilization

[10603295511342]

Moist Heat or Steam Sterilization

[10603295511342]

Moist Heat or Steam Sterilization

[10603295511342]

Moist Heat or Steam Sterilization

[10603295511342]

Moist Heat or Steam Sterilization

[10603295511342]

Moist Heat or Steam Sterilization

[10603295511342]

Moist Heat or Steam Sterilization

[10603295511342]

Moist Heat or Steam Sterilization

[10603295511342]

Moist Heat or Steam Sterilization

[10603295511342]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-05-03
• Device Publish Date: 2019-08-12

On-Brand Devices [ATTUNE]

• 10603295493518: ATTUNE KNEE SYSTEM TIBIAL INSERT TRIAL ROTATING PLATFORM POSTERIOR STABILIZED SIZE 10 14mm
• 10603295493501: ATTUNE KNEE SYSTEM TIBIAL INSERT TRIAL ROTATING PLATFORM POSTERIOR STABILIZED SIZE 9 20mm
• 10603295493495: ATTUNE KNEE SYSTEM TIBIAL INSERT TRIAL ROTATING PLATFORM POSTERIOR STABILIZED SIZE 9 18mm
• 10603295493488: ATTUNE KNEE SYSTEM TIBIAL INSERT TRIAL ROTATING PLATFORM POSTERIOR STABILIZED SIZE 9 16mm
• 10603295493471: ATTUNE KNEE SYSTEM TIBIAL INSERT TRIAL ROTATING PLATFORM POSTERIOR STABILIZED SIZE 9 14mm
• 10603295493464: ATTUNE KNEE SYSTEM TIBIAL INSERT TRIAL ROTATING PLATFORM POSTERIOR STABILIZED SIZE 8 20mm
• 10603295493457: ATTUNE KNEE SYSTEM TIBIAL INSERT TRIAL ROTATING PLATFORM POSTERIOR STABILIZED SIZE 8 18mm
• 10603295493440: ATTUNE KNEE SYSTEM TIBIAL INSERT TRIAL ROTATING PLATFORM POSTERIOR STABILIZED SIZE 8 16mm
• 10603295493433: ATTUNE KNEE SYSTEM TIBIAL INSERT TRIAL ROTATING PLATFORM POSTERIOR STABILIZED SIZE 8 14mm
• 10603295493013: ATTUNE KNEE SYSTEM TIBIAL INSERT TRIAL ROTATING PLATFORM POSTERIOR STABILIZED SIZE 10 20mm
• 10603295493006: ATTUNE KNEE SYSTEM TIBIAL INSERT TRIAL ROTATING PLATFORM POSTERIOR STABILIZED SIZE 10 18mm
• 10603295492993: ATTUNE KNEE SYSTEM TIBIAL INSERT TRIAL ROTATING PLATFORM POSTERIOR STABILIZED SIZE 10 16mm
• 10603295481638: ATTUNE KNEE SYSTEM TIBIAL INSERT TRIALS TRAY PS RP SIZE 3-10, 14-20mm
• 10603295481607: ATTUNE KNEE SYSTEM TIBIAL INSERT TRIALS TRAY RP SIZE 1-2, 5-18mm
• 10603295481577: ATTUNE KNEE SYSTEM TIBIAL INSERT TRIALS TRAY PS FB SIZE 3-10, 14-20mm
• 10603295481553: ATTUNE KNEE SYSTEM TIBIAL INSERT TRIALS TRAY CR SIZE 3-10, 14-16mm
• 10603295481546: ATTUNE KNEE SYSTEM TIBIAL INSERT TRIALS TRAY FB SIZE 1-2, 5-18mm
• 10603295484141: ATTUNE Make to Order Intuition Tibia Patella Preparation Sterilization Tray
• 10603295484134: ATTUNE Make to Order Intuition Primary Preparation Sterilization Tray
• 10603295455752: ATTUNE MAKE TO ORDER FIXED BEARING POSTERIOR STABILIZED INSERT TRIAL TRAY SIZE 3-8
• 10603295455745: ATTUNE MAKE TO ORDER FIXED BEARING CRUCIATE RETAINING INSERT TRIAL TRAY SIZE 3-8
• 10603295442066: ATTUNE MI TRAY
• 10603295494225: ATTUNE MAKE TO ORDER Fixed Bearing Cruciate Retaining Tibial Insert Trial SIZE: 9, 3MM
• 10603295494218: ATTUNE MAKE TO ORDER Fixed Bearing Cruciate Retaining Tibial Insert Trial SIZE: 8, 3MM
• 10603295494201: ATTUNE MAKE TO ORDER Fixed Bearing Cruciate Retaining Tibial Insert Trial SIZE: 7, 3MM
• 10603295494195: ATTUNE MAKE TO ORDER Fixed Bearing Cruciate Retaining Tibial Insert Trial SIZE: 6, 3MM
• 10603295494188: ATTUNE MAKE TO ORDER Fixed Bearing Cruciate Retaining Tibial Insert Trial SIZE: 3, 3MM
• 10603295494171: ATTUNE MAKE TO ORDER Fixed Bearing Cruciate Retaining Tibial Insert Trial SIZE: 10, 3MM
• 10603295494164: ATTUNE MAKE TO ORDER Fixed Bearing Cruciate Retaining Tibial Insert Trial SIZE: 5, 3MM
• 10603295494157: ATTUNE MAKE TO ORDER Fixed Bearing Cruciate Retaining Tibial Insert Trial SIZE: 4, 3MM
• 10603295454120: MAKE TO ORDER ATTUNE FIXED BEARING POSTERIOR STABILIZING INSERT TRIAL SIZE 3 5MM
• 10603295454113: ATTUNE MAKE TO ORDER FEMORAL NOTCH TRIAL SIZE 9
• 10603295454106: ATTUNE MAKE TO ORDER FEMORAL NOTCH TRIAL SIZE 8
• 10603295454090: ATTUNE MAKE TO ORDER FEMORAL NOTCH TRIAL SIZE 7
• 10603295454083: ATTUNE MAKE TO ORDER FEMORAL NOTCH TRIAL SIZE 6
• 10603295454076: ATTUNE MAKE TO ORDER FEMORAL NOTCH TRIAL SIZE 5
• 10603295454069: ATTUNE MAKE TO ORDER FEMORAL NOTCH TRIAL SIZE 4
• 10603295454052: ATTUNE MAKE TO ORDER FEMORAL NOTCH TRIAL SIZE 3
• 10603295454045: ATTUNE MAKE TO ORDER FEMORAL NOTCH TRIAL SIZE 2
• 10603295454038: ATTUNE MAKE TO ORDER FEMORAL NOTCH TRIAL SIZE 10
• 10603295454021: ATTUNE MAKE TO ORDER FEMORAL NOTCH TRIAL SIZE 1
• 10603295454014: ATTUNE MAKE TO ORDER FIXED BEARING POSTERIOR STABILIZING INSERT TRIAL SIZE 8 8MM
• 10603295454007: ATTUNE MAKE TO ORDER FIXED BEARING POSTERIOR STABILIZING INSERT TRIAL SIZE 8 7MM
• 10603295453994: ATTUNE MAKE TO ORDER FIXED BEARING POSTERIOR STABILIZING INSERT TRIAL SIZE 8 6MM
• 10603295453987: ATTUNE MAKE TO ORDER FIXED BEARING POSTERIOR STABILIZING INSERT TRIAL SIZE 8 5MM
• 10603295453970: ATTUNE MAKE TO ORDER FIXED BEARING POSTERIOR STABILIZING INSERT TRIAL SIZE 8 12MM
• 10603295453963: ATTUNE MAKE TO ORDER FIXED BEARING POSTERIOR STABILIZING INSERT TRIAL SIZE 8 10MM
• 10603295453956: ATTUNE MAKE TO ORDER FIXED BEARING POSTERIOR STABILIZING INSERT TRIAL SIZE 7 8MM
• 10603295453949: ATTUNE MAKE TO ORDER FIXED BEARING POSTERIOR STABILIZING INSERT TRIAL SIZE 7 7MM
• 10603295453932: ATTUNE MAKE TO ORDER FIXED BEARING POSTERIOR STABILIZING INSERT TRIAL SIZE 7 6MM