BIOLOX DELTA 136528710

GUDID 10603295033301

BIOLOX DELTA TS CERAMIC FEMORAL HEAD 12/14 TAPER REVISION Diameter 28mm +1.5

DEPUY ORTHOPAEDICS, INC.

Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis

• Primary Device ID: 10603295033301
• NIH Device Record Key: 32e3d89f-7b65-4de2-8901-5af0471afa51
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOLOX DELTA
• Version Model Number: 1365-28-710
• Catalog Number: 136528710
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295033301 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073570

FDA Product Code

• KWA: Prosthesis, hip, semi-constrained (metal uncemented acetabular component)

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: 2015-03-24

On-Brand Devices [BIOLOX DELTA]

• 10603295033844: BIOLOX DELTA TS CERAMIC FEMORAL HEAD 12/14 TAPER REVISION Diameter 44mm +12
• 10603295033837: BIOLOX DELTA TS CERAMIC FEMORAL HEAD 12/14 TAPER REVISION Diameter 44mm +8.5
• 10603295033820: BIOLOX DELTA TS CERAMIC FEMORAL HEAD 12/14 TAPER REVISION Diameter 44mm +5
• 10603295033813: BIOLOX DELTA TS CERAMIC FEMORAL HEAD 12/14 TAPER REVISION Diameter 44mm +1.5
• 10603295033721: BIOLOX DELTA TS CERAMIC FEMORAL HEAD 12/14 TAPER REVISION Diameter 40mm +12
• 10603295033714: BIOLOX DELTA TS CERAMIC FEMORAL HEAD 12/14 TAPER REVISION Diameter 40mm +8.5
• 10603295033707: BIOLOX DELTA TS CERAMIC FEMORAL HEAD 12/14 TAPER REVISION Diameter 40mm +5
• 10603295033691: BIOLOX DELTA TS CERAMIC FEMORAL HEAD 12/14 TAPER REVISION Diameter 40mm +1.5
• 10603295033684: BIOLOX DELTA TS CERAMIC FEMORAL HEAD 12/14 TAPER REVISION Diameter 36mm +12
• 10603295033677: BIOLOX DELTA TS CERAMIC FEMORAL HEAD 12/14 TAPER REVISION Diameter 36mm +8.5
• 10603295033660: BIOLOX DELTA TS CERAMIC FEMORAL HEAD 12/14 TAPER REVISION Diameter 36mm +5
• 10603295033653: BIOLOX DELTA TS CERAMIC FEMORAL HEAD 12/14 TAPER REVISION Diameter 36mm +1.5
• 10603295033646: BIOLOX DELTA CERAMIC FEMORAL HEAD +12 36mm DIA 12/14 TAPER
• 10603295033639: BIOLOX DELTA CERAMIC FEMORAL HEAD +8.5 36mm DIA 12/14 TAPER
• 10603295033622: BIOLOX DELTA CERAMIC FEMORAL HEAD +5.0 36mm DIA 12/14 TAPER
• 10603295033615: BIOLOX DELTA CERAMIC FEMORAL HEAD +1.5 36mm DIA 12/14 TAPER
• 10603295033608: BIOLOX DELTA CERAMIC FEMORAL HEAD 36mm DIA +12 11/13 TAPER
• 10603295033592: BIOLOX DELTA CERAMIC FEMORAL HEAD +9 36mm DIA 11/13 TAPER
• 10603295033585: BIOLOX DELTA CERAMIC FEMORAL HEAD +6 36mm DIA 11/13 TAPER
• 10603295033578: BIOLOX DELTA CERAMIC FEMORAL HEAD +3 36mm DIA 11/13 TAPER
• 10603295033561: BIOLOX DELTA CERAMIC FEMORAL HEAD +0 36mm DIA 11/13 TAPER
• 10603295033486: BIOLOX DELTA TS CERAMIC FEMORAL HEAD 12/14 TAPER REVISION Diameter 32mm +9
• 10603295033479: BIOLOX DELTA TS CERAMIC FEMORAL HEAD 12/14 TAPER REVISION Diameter 32mm +5
• 10603295033462: BIOLOX DELTA TS CERAMIC FEMORAL HEAD 12/14 TAPER REVISION Diameter 32mm +1
• 10603295033455: BIOLOX DELTA CERAMIC FEMORAL HEAD 32mm DIA +9 12/14 TAPER
• 10603295033448: BIOLOX DELTA CERAMIC FEMORAL HEAD 32mm DIA +5.0 12/14 TAPER
• 10603295033431: BIOLOX DELTA CERAMIC FEMORAL HEAD 32mm DIA +1 12/14 TAPER
• 10603295033424: BIOLOX DELTA CERAMIC FEMORAL HEAD 32mm DIA +6 11/13 TAPER
• 10603295033417: BIOLOX DELTA CERAMIC FEMORAL HEAD 32mm DIA +3 11/13 TAPER
• 10603295033400: BIOLOX DELTA CERAMIC FEMORAL HEAD 32mm DIA +0 11/13 TAPER
• 10603295033332: BIOLOX DELTA TS CERAMIC FEMORAL HEAD 12/14 TAPER REVISION Diameter 28mm +12
• 10603295033325: BIOLOX DELTA TS CERAMIC FEMORAL HEAD 12/14 TAPER REVISION Diameter 28mm +8.5
• 10603295033318: BIOLOX DELTA TS CERAMIC FEMORAL HEAD 12/14 TAPER REVISION Diameter 28mm +5
• 10603295033301: BIOLOX DELTA TS CERAMIC FEMORAL HEAD 12/14 TAPER REVISION Diameter 28mm +1.5
• 10603295033295: BIOLOX DELTA CERAMIC FEMORAL HEAD 28mm DIA +8.5 12/14 TAPER
• 10603295033288: BIOLOX DELTA CERAMIC FEMORAL HEAD 28mm DIA +5.0 12/14 TAPER
• 10603295033271: BIOLOX DELTA CERAMIC FEMORAL HEAD 28mm DIA +1.5 12/14 TAPER
• 10603295033264: BIOLOX DELTA CERAMIC FEMORAL HEAD Diameter 28mm +6 11/13 TAPER
• 10603295033257: BIOLOX DELTA CERAMIC FEMORAL HEAD Diameter 28mm +3 11/13 TAPER
• 10603295033240: BIOLOX DELTA CERAMIC FEMORAL HEAD Diameter 28mm +0 11/13 TAPER