BIOLOX DELTA 136536710
GUDID 10603295033653
BIOLOX DELTA TS CERAMIC FEMORAL HEAD 12/14 TAPER REVISION Diameter 36mm +1.5
DEPUY ORTHOPAEDICS, INC.
Ceramic femoral head prosthesis| Primary Device ID | 10603295033653 |
| NIH Device Record Key | 4e66ec09-38c0-41f5-9058-bdab252ff234 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BIOLOX DELTA |
| Version Model Number | 1365-36-710 |
| Catalog Number | 136536710 |
| 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 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10603295033653 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K073570
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 | 2015-03-24 |
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 |
Trademark Results [BIOLOX DELTA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIOLOX DELTA 85523572 4337105 Dead/Cancelled |
CeramTec GmbH 2012-01-24 |
 BIOLOX DELTA 79376201 not registered Live/Pending |
CeramTec GmbH 2023-07-11 |
 BIOLOX DELTA 79180041 5097823 Live/Registered |
CeramTec GmbH 2015-10-13 |
 BIOLOX DELTA 76689704 3707260 Live/Registered |
CERAMTEC GMBH 2008-05-16 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.