PINNACLE 121707070

GUDID 10603295008958

PINNACLE HIP SOLUTIONS REVISION POROCOAT (DPX) ACETABULAR SHELL DEEP PROFILE 70mm OD 64mm LINER

DEPUY ORTHOPAEDICS, INC.

Acetabular shell

• Primary Device ID: 10603295008958
• NIH Device Record Key: b4f921d3-0e12-44cd-b184-d1bcdd765f97
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PINNACLE
• Version Model Number: 1217-07-070
• Catalog Number: 121707070
• 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: 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(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
• 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
• 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	10603295008958 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033338

FDA Product Code

• LPH: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-09-09
• Device Publish Date: 2015-09-24

On-Brand Devices [PINNACLE]

• 10603295511533: PINNACLE TRI-FLANGE ACETABULAR CUP W/ HA (TF022119.004) FOR CEMENTLESS USE ONLY 56MM LEFT
• 10603295510949: PINNACLE TRI-FLANGE ACETABULAR CUP W/ HA (TF121218.005) FOR CEMENTLESS USE ONLY 66MM RIGHT
• 10603295511571: PINNACLE TRI-FLANGE ACETABULAR CUP W/ HA (TF111418.004) FOR CEMENTLESS USE ONLY 56MM LEFT
• 10603295511564: PINNACLE TRI-FLANGE ACETABULAR CUP W/ HA (TF030719.005) FOR CEMENTLESS USE ONLY 62MM LEFT
• 10603295511519: PINNACLE TRI-FLANGE ACETABULAR CUP W/ HA (TF011019.005) FOR CEMENTLESS USE ONLY 52MM RIGHT
• 10603295511557: PINNACLE TRI-FLANGE ACETABULAR CUP W/ HA (TF021419.003) FOR CEMENTLESS USE ONLY 62MM RIGHT
• 10603295102359: PINNACLE GRIPPER 66mm
• 10603295102342: PINNACLE GRIPPER 64mm
• 10603295102335: PINNACLE GRIPPER 62mm
• 10603295102328: PINNACLE GRIPPER 60mm
• 10603295102311: PINNACLE GRIPPER 58mm
• 10603295102304: PINNACLE GRIPPER 56mm
• 10603295102298: PINNACLE GRIPPER 54mm
• 10603295102281: PINNACLE GRIPPER 52mm
• 10603295102274: PINNACLE GRIPPER 50mm
• 10603295102267: PINNACLE GRIPPER 48mm
• 10603295102250: PINNACLE GRIPPER 46mm
• 10603295102243: PINNACLE GRIPPER 44mm
• 10603295102236: PINNACLE AB GRIPPER TIP 32mm
• 10603295102229: PINNACLE TIP 44mm
• 10603295102212: PINNACLE TIP 40mm
• 10603295102199: PINNACLE TIP 36mm
• 10603295102182: PINNACLE TIP 28mm
• 10603295098928: PINNACLE POLY EXTRACTOR
• 10603295097358: PINNACLE ALTER BEARING EXTRACTOR BODY 66mm
• 10603295097341: PINNACLE ALTER BEARING EXTRACTOR BODY 64mm
• 10603295097334: PINNACLE ALTER BEARING EXTRACTOR BODY 62mm
• 10603295097327: PINNACLE ALTER BEARING EXTRACTOR BODY 60mm
• 10603295097310: PINNACLE ALTER BEARING EXTRACTOR BODY 58mm
• 10603295097303: PINNACLE ALTER BEARING EXTRACTOR BODY 56mm
• 10603295097297: PINNACLE ALTER BEARING EXTRACTOR BODY 54mm
• 10603295097280: PINNACLE ALTER BEARING EXTRACTOR BODY 52mm
• 10603295097273: PINNACLE ALTER BEARING EXTRACTOR BODY 50mm
• 10603295097266: PINNACLE ALTER BEARING EXTRACTOR BODY 48mm
• 10603295097259: PINNACLE ALTER BEARING EXTRACTOR BODY 46mm
• 10603295097242: PINNACLE ALTER BEARING EXTRACTOR BODY 44mm
• 10603295097235: PINNACLE ALTERNATE BEARING SUCTION CUP INSERTER
• 10603295511052: PINNACLE TRI-FLANGE ACETABULAR CUP W/ HA (TF113018.013) FOR CEMENTLESS USE ONLY 56MM RIGHT
• 10603295511717: PINNACLE TRI-FLANGE ACETABULAR CUP W/ HA (TF032119.009) FOR CEMENTLESS USE ONLY 56MM LEFT
• 10603295511670: PINNACLE TRI-FLANGE ACETABULAR CUP W/ HA (TF032019.008) FOR CEMENTLESS USE ONLY 54MM RIGHT
• 10603295510956: PINNACLE TRI-FLANGE ACETABULAR CUP W/ HA (TF112618.012) FOR CEMENTLESS USE ONLY 48MM RIGHT
• 10603295511649: PINNACLE TRI-FLANGE ACETABULAR CUP W/ HA (TF041619.006) FOR CEMENTLESS USE ONLY 66MM LEFT
• 10603295511588: PINNACLE TRI-FLANGE ACETABULAR CUP W/O HA (TF030419.002) FOR CEMENTLESS USE ONLY 56MM RIGHT
• 10603295511083: PINNACLE TRI-FLANGE ACETABULAR CUP W/ HA (TF121118.003) FOR CEMENTLESS USE ONLY 56MM RIGHT
• 10603295514091: PINNACLE TRI-FLANGE ACETABULAR CUP W/ HA (TF060419.001) FOR CEMENTLESS USE ONLY 54MM RIGHT
• 10603295513377: PINNACLE TRI-FLANGE ACETABULAR CUP W/ HA (TF061419.006) FOR CEMENTLESS USE ONLY 58MM LEFT
• 10603295513353: PINNACLE TRI-FLANGE ACETABULAR CUP W/ HA (TF071719.006) FOR CEMENTLESS USE ONLY 52MM LEFT
• 10603295513391: PINNACLE TRI-FLANGE ACETABULAR CUP W/ HA (TF072319.007) FOR CEMENTLESS USE ONLY 48MM LEFT
• 10603295513384: PINNACLE TRI-FLANGE ACETABULAR CUP W/ HA (TF060519.002) FOR CEMENTLESS USE ONLY 66MM LEFT
• 10603295511700: PINNACLE TRI-FLANGE ACETABULAR CUP W/ HA (TF100418.001) FOR CEMENTLESS USE ONLY 50MM RIGHT