BIOLOX® OPTION 00-8777-028-01
GUDID 00889024430433
BIOLOX® OPTION, HEAD, S, Ø 28/-3.0, TAPER 12/14
Zimmer GmbH
Ceramic femoral head prosthesis| Primary Device ID | 00889024430433 |
| NIH Device Record Key | fe5e32ba-5d27-4b82-bd17-8fba33c7be01 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BIOLOX® OPTION |
| Version Model Number | 00-8777-028-01 |
| Catalog Number | 00-8777-028-01 |
| 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 | 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
Device Dimensions
| Outer Diameter | 28 Millimeter |
| Length | -3 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 28 Millimeter |
| Length | -3 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 28 Millimeter |
| Length | -3 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 28 Millimeter |
| Length | -3 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 28 Millimeter |
| Length | -3 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 28 Millimeter |
| Length | -3 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 28 Millimeter |
| Length | -3 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 28 Millimeter |
| Length | -3 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 28 Millimeter |
| Length | -3 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 28 Millimeter |
| Length | -3 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 28 Millimeter |
| Length | -3 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 28 Millimeter |
| Length | -3 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 28 Millimeter |
| Length | -3 Millimeter |
| Device Size Text, specify | 0 |
| Outer Diameter | 28 Millimeter |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889024430433 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K073567
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 | 2019-10-25 |
| Device Publish Date | 2016-08-29 |
On-Brand Devices [BIOLOX® OPTION]
| 00889024430587 | BIOLOX® OPTION, HEAD, XL, Ø 40/+7, TAPER 12/14 |
| 00889024430570 | BIOLOX® OPTION, HEAD, L, Ø 40/+3.5, TAPER 12/14 |
| 00889024430563 | BIOLOX® OPTION, HEAD, M, Ø 40/0, TAPER 12/14 |
| 00889024430556 | BIOLOX® OPTION, HEAD, S, Ø 40/-3.0, TAPER 12/14 |
| 00889024430549 | BIOLOX® OPTION, HEAD, XL, Ø 36/+7, TAPER 12/14 |
| 00889024430532 | BIOLOX® OPTION, HEAD, L, Ø 36/+3.5, TAPER 12/14 |
| 00889024430525 | BIOLOX® OPTION, HEAD, M, Ø 36/0, TAPER 12/14 |
| 00889024430518 | BIOLOX® OPTION, HEAD, S, Ø 36/-3.0, TAPER 12/14 |
| 00889024430501 | BIOLOX® OPTION, HEAD, XL, Ø 32/+7, TAPER 12/14 |
| 00889024430495 | BIOLOX® OPTION, HEAD, L, Ø 32/+3.5, TAPER 12/14 |
| 00889024430488 | BIOLOX® OPTION, HEAD, M, Ø 32/0, TAPER 12/14 |
| 00889024430471 | BIOLOX® OPTION, HEAD, S, Ø 32/-3.0, TAPER 12/14 |
| 00889024430464 | BIOLOX® OPTION, HEAD, XL, Ø 28/+7, TAPER 12/14 |
| 00889024430457 | BIOLOX® OPTION, HEAD, L, Ø 28/+3.5, TAPER 12/14 |
| 00889024430440 | BIOLOX® OPTION, HEAD, M, Ø 28/0, TAPER 12/14 |
| 00889024430433 | BIOLOX® OPTION, HEAD, S, Ø 28/-3.0, TAPER 12/14 |
| 00889024277007 | BIOLOX® OPTION, head, XL, ø 40/+7, taper 12/14 |
| 00889024276994 | BIOLOX® OPTION, head, L, ø 40/+3.5, taper 12/14 |
| 00889024276987 | BIOLOX® OPTION, head, M, ø 40/0, taper 12/14 |
| 00889024276970 | BIOLOX® OPTION, head, S, ø 40/-3.0, taper 12/14 |
| 00889024276963 | BIOLOX® OPTION, head, XL, ø 36/+7, taper 12/14 |
| 00889024276956 | BIOLOX® OPTION, head, L, ø 36/+3.5, taper 12/14 |
| 00889024276949 | BIOLOX® OPTION, head, M, ø 36/0, taper 12/14 |
| 00889024276932 | BIOLOX® OPTION, head, S, ø 36/-3.0, taper 12/14 |
| 00889024276925 | BIOLOX® OPTION, head, XL, ø 32/+7, taper 12/14 |
| 00889024276918 | BIOLOX® OPTION, head, L, ø 32/+3.5, taper 12/14 |
| 00889024276901 | BIOLOX® OPTION, head, M, ø 32/0, taper 12/14 |
| 00889024276895 | Biolox® OPTION Hd/Adpt, 12/14, 32 x -3.0 |
| 00889024276888 | BIOLOX® OPTION, head, XL, ø 28/+7, taper 12/14 |
| 00889024276871 | Biolox® OPTION Hd/Adpt, 12/14, 28 x +3.5 |
| 00889024276864 | BIOLOX® OPTION, head, M, ø 28/0, taper 12/14 |
| 00889024276857 | BIOLOX® OPTION, head, S, ø 28/-3.0, taper 12/14 |
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 |
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