HipMap Femoroacetabular Impingement Analysis 3105001000

GUDID 07613327382570

STRYKER CORPORATION

Radiology DICOM image processing application software

• Primary Device ID: 07613327382570
• NIH Device Record Key: fb9c70d1-fd8a-4a7b-9497-484c50f87107
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HipMap Femoroacetabular Impingement Analysis
• Version Model Number: 3105001000
• Catalog Number: 3105001000
• Company DUNS: 187502109
• Company Name: STRYKER CORPORATION
• 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: 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: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327382570 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230045

FDA Product Code

• QIH: Automated Radiological Image Processing Software

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-22
• Device Publish Date: 2023-12-14

Devices Manufactured by STRYKER CORPORATION

• 07613327261844 - O.I.C. TITANIUM: 2026-02-09 CAGE IMPACTOR
• 07613327261868 - O.I.C. TITANIUM: 2026-02-09 FINAL CAGE IMPACTOR
• 07613327264722 - XIA 4.5: 2026-02-09 HOOK IMPACTOR
• 07613327264753 - XIA 4.5: 2026-02-09 DUAL STAPLE IMPACTOR
• 07613327265460 - XIA 3: 2026-02-09 HOOK IMPACTOR
• 07613327267037 - VLIFT: 2026-02-09 ENDCAP IMPACTOR
• 07613327267068 - VLIFT: 2026-02-09 ENDCAP IMPACTOR
• 07613327267563 - AVS: 2026-02-09 AS SPACER IMPACTOR STRAIGHT