S-ROM 523208

GUDID 10603295170945

S-ROM Total Hip System FEMORAL STEM Standard 30 STD NECK 11/13 TAPER 14x08x130

DEPUY ORTHOPAEDICS, INC.

Uncoated hip femur prosthesis, modular

• Primary Device ID: 10603295170945
• NIH Device Record Key: 06121b50-8f5f-4629-8e05-502429f1bdbc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: S-ROM
• Version Model Number: 52-3208
• Catalog Number: 523208
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295170945 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K954935

FDA Product Code

• MRA: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or 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: 2021-05-20
• Device Publish Date: 2015-03-24

On-Brand Devices [S-ROM]

• 10603295175148: S-ROM PIN AND SCREW INSERTER 5.0mm
• 10603295175131: S-ROM PIN AND SCREW INSERTER 3.5mm
• 10603295172901: S-ROM STEMSLEEVE SEPARATOR
• 10603295172703: S-ROM TRIAL SLEEVE EXTRACTOR
• 10603295172017: S-ROM BLADE SLEEVE EXTRACTOR SIZE 22/24
• 10603295172000: S-ROM BLADE SLEEVE EXTRACTOR SIZE 18/20
• 10603295171997: S-ROM BLADE SLEEVE EXTRACTOR SIZE 14/16
• 10603295171980: S-ROM EXTRACTOR SLEEVE SPA & ZT
• 10603295171973: S-ROM STEM EXTRACTOR LOOP
• 10603295146001: S-ROM MI MILLER SHELL INSERTER / EXTRACTOR
• 10603295145981: S-ROM MI INSERTER FORK SIZE 30 STANDARD
• 10603295145974: S-ROM MI INSERTER FORK LARGE
• 10603295145967: S-ROM MI INSERTER FORK MEDIUM
• 10603295145950: S-ROM MI INSERTER FORK SMALL
• 10603295145943: S-ROM MI STEM INSERTER
• 10603295145318: S-ROM TRIAL SLEEVE EXTRACTOR
• 10603295172642: S-ROM FLEXIBLE SHAFT 1/4 DIA
• 10603295172604: S-ROM SCREW CLAMP
• 10603295171652: S-ROM LINER TURNER
• 10603295034407: S-ROM M-Spec FEMORAL HEAD Diameter 48mm +12 Offset 11/13 TAPER
• 10603295034377: S-ROM M-Spec FEMORAL HEAD Diameter 48mm +6 OFFSET 11/13 TAPER
• 10603295034308: S-ROM M-Spec FEMORAL HEAD Diameter 48mm +3 OFFSET 11/13 TAPER
• 10603295034285: S-ROM M-Spec FEMORAL HEAD Diameter 48mm +0 Offset 11/13 TAPER
• 10603295034230: S-ROM M-Spec FEMORAL HEAD Diameter 44mm +12 Offset 11/13 TAPER
• 10603295034216: S-ROM M-Spec FEMORAL HEAD Diameter 44mm +9 Offset 11/13 TAPER
• 10603295034179: S-ROM M-Spec FEMORAL HEAD Diameter 44mm +6 Offset 11/13 TAPER
• 10603295034131: S-ROM M-Spec FEMORAL HEAD Diameter 44mm +3 Offset 11/13 TAPER
• 10603295034094: S-ROM M-Spec FEMORAL HEAD Diameter 44mm +0 Offset 11/13 TAPER
• 10603295034056: S-ROM M-Spec FEMORAL HEAD Diameter 44mm -3 Offset 11/13 TAPER
• 10603295033875: S-ROM M-Spec FEMORAL HEAD Diameter 40mm +12 Offset 11/13 TAPER
• 10603295033851: S-ROM M-Spec FEMORAL HEAD Diameter 40mm +9 Offset 11/13 TAPER
• 10603295033790: S-ROM M-Spec FEMORAL HEAD Diameter 40mm +6 Offset 11/13 TAPER
• 10603295033776: S-ROM M-Spec FEMORAL HEAD Diameter 40mm +3 Offset 11/13 TAPER
• 10603295033752: S-ROM M-Spec FEMORAL HEAD Diameter 40mm +0 Offset 11/13 TAPER
• 10603295033738: S-ROM M-Spec FEMORAL HEAD Diameter 40mm -3 Offset 11/13 TAPER
• 10603295033387: S-ROM M METAL ON METAL FEMORAL HEAD Diameter 36mm +3 11/13 TAPER
• 10603295033363: S-ROM M METAL ON METAL FEMORAL HEAD Diameter 36mm +0 11/13 TAPER
• 10603295033226: S-ROM M METAL ON METAL FEMORAL HEAD Diameter 36mm -3 11/13 TAPER
• 10603295033165: S-ROM M METAL ON METAL FEMORAL HEAD Diameter 28mm +6 11/13 TAPER ULTAMET
• 10603295033158: S-ROM M METAL ON METAL FEMORAL HEAD Diameter 28mm +3 11/13 TAPER ULTAMET
• 10603295173663: S-ROM TRIANGLE MILLER CUTTER 24mm
• 10603295173656: S-ROM TRIANGLE MILLER CUTTER 22mm
• 10603295173649: S-ROM TRIANGLE MILLER CUTTER 20mm
• 10603295173632: S-ROM TRIANGLE MILLER CUTTER 18mm
• 10603295173625: S-ROM TRIANGLE MILLER CUTTER 16mm
• 10603295173618: S-ROM TRIANGLE MILLER CUTTER 14mm
• 10603295173595: S-ROM TRIANGLE MILLER SHELL SIZE 2N
• 10603295173588: S-ROM TRIANGLE MILLER SHELL SIZE 9
• 10603295173571: S-ROM TRIANGLE MILLER SHELL SIZE 8
• 10603295173564: S-ROM TRIANGLE MILLER SHELL SIZE 7