BIOLOX DELTA 136532220

GUDID 10603295033417

BIOLOX DELTA CERAMIC FEMORAL HEAD 32mm DIA +3 11/13 TAPER

DEPUY ORTHOPAEDICS, INC.

Ceramic femoral head prosthesis

• Primary Device ID: 10603295033417
• NIH Device Record Key: f051780c-4971-4789-a3cd-890a2e1da89f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOLOX DELTA
• Version Model Number: 1365-32-220
• Catalog Number: 136532220
• 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	10603295033417 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031803

FDA Product Code

• LZO: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-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 [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