Biolox® delta
GUDID 00889024276802
BIOLOX® delta, Ceramic Femoral Head, XL, ø 36/+7, taper 12/14
Zimmer GmbH
Ceramic femoral head prosthesis| Primary Device ID | 00889024276802 |
| NIH Device Record Key | 53de2c5c-f773-4036-a08c-6a9647976ea6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Biolox® delta |
| Version Model Number | 00-8775-036-04 |
| Company DUNS | 488133448 |
| Company Name | Zimmer GmbH |
| 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 | true |
| 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)348-2759 |
| zimmer.consumerrelations@zimmer.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmer.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmer.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmer.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmer.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmer.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmer.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmer.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmer.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmer.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmer.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmer.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmer.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmer.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Outer Diameter | 36 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Outer Diameter | 36 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Outer Diameter | 36 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Outer Diameter | 36 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Outer Diameter | 36 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Outer Diameter | 36 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Outer Diameter | 36 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Outer Diameter | 36 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Outer Diameter | 36 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Outer Diameter | 36 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Outer Diameter | 36 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Outer Diameter | 36 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 7 degree |
| Outer Diameter | 36 Millimeter |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889024276802 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K071535
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 | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-08-29 |
On-Brand Devices [Biolox® delta]
| 00889024430426 | BIOLOX® DELTA, CERAMIC FEMORAL HEAD, XL, Ø 40/+7, TAPER 12/14 |
| 00889024430419 | BIOLOX® DELTA, FEMORAL HEAD, L, CERAMIC, Ø 40/+3.5, TAPER 12/14 |
| 00889024430402 | BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, Ø 40/0, TAPER 12/14 |
| 00889024430396 | BIOLOX® DELTA, CERAMIC FEMORAL HEAD, S, Ø 40/-3.5, TAPER 12/14 |
| 00889024430389 | BIOLOX® DELTA, CERAMIC FEMORAL HEAD, XL, Ø 36/+7, TAPER 12/14 |
| 00889024430372 | BIOLOX® DELTA, CERAMIC FEMORAL HEAD, L, Ø 36/+3.5, TAPER 12/14 |
| 00889024430365 | BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, Ø 36/0, TAPER 12/14 |
| 00889024430358 | BIOLOX® DELTA, CERAMIC FEMORAL HEAD, S, Ø 36/-3.5, TAPER 12/14 |
| 00889024430341 | BIOLOX® DELTA, CERAMIC FEMORAL HEAD, XL, Ø 32/+7, TAPER 12/14 |
| 00889024430334 | BIOLOX® DELTA, CERAMIC FEMORAL HEAD, L, Ø 32/+3.5, TAPER 12/14 |
| 00889024430327 | BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, Ø 32/0, TAPER 12/14 |
| 00889024430310 | BIOLOX® DELTA, CERAMIC FEMORAL HEAD, S, Ø 32/-3.5, TAPER 12/14 |
| 00889024430303 | BIOLOX® DELTA, CERAMIC FEMORAL HEAD, L, Ø 28/+3.5, TAPER 12/14 |
| 00889024430297 | BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, Ø 28/0, TAPER 12/14 |
| 00889024430280 | BIOLOX® DELTA, CERAMIC FEMORAL HEAD, S, Ø 28/-3.5, TAPER 12/14 |
| 00889024276840 | BIOLOX® delta, Ceramic Femoral Head, XL, ø 40/+7, taper 12/14 |
| 00889024276833 | BIOLOX® delta, Femoral Head, L, ceramic, ø 40/+3.5, taper 12/14 |
| 00889024276826 | BIOLOX® delta, Ceramic Femoral Head, M, ø 40/0, taper 12/14 |
| 00889024276819 | BIOLOX® delta, Ceramic Femoral Head, S, ø 40/-3.5, taper 12/14 |
| 00889024276802 | BIOLOX® delta, Ceramic Femoral Head, XL, ø 36/+7, taper 12/14 |
| 00889024276796 | BIOLOX® delta, Ceramic Femoral Head, L, ø 36/+3.5, taper 12/14 |
| 00889024276789 | BIOLOX® delta, Ceramic Femoral Head, M, ø 36/0, taper 12/14 |
| 00889024276772 | BIOLOX® delta, Ceramic Femoral Head, S, ø 36/-3.5, taper 12/14 |
| 00889024276765 | BIOLOX® delta, Ceramic Femoral Head, XL, ø 32/+7, taper 12/14 |
| 00889024276758 | BIOLOX® delta, Ceramic Femoral Head, L, ø 32/+3.5, taper 12/14 |
| 00889024276741 | BIOLOX® delta, Ceramic Femoral Head, M, ø 32/0, taper 12/14 |
| 00889024276734 | BIOLOX® delta, Ceramic Femoral Head, S, ø 32/-3.5, taper 12/14 |
| 00889024276727 | BIOLOX® delta, Ceramic Femoral Head, L, ø 28/+3.5, taper 12/14 |
| 00889024276710 | BIOLOX® delta, Ceramic Femoral Head, M, ø 28/0, taper 12/14 |
| H84400877502801 | Biolox® delta Head, 12/14, 28 x -3.5 |
Trademark Results [Biolox]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIOLOX 79278180 not registered Live/Pending |
Cerasiv GmbH Innovatives Keramik-Engineering 2019-09-24 |
 BIOLOX 73078031 1068905 Live/Registered |
FELDMUHLE ANLAGEN- UND PRODUKTIONS-GMBH 1976-02-23 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.