BIOLOX® OPTION 00-8777-040-01
GUDID 00889024430556
BIOLOX® OPTION, HEAD, S, Ø 40/-3.0, TAPER 12/14
Zimmer GmbH
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 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 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 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 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 | 00889024430556 |
| NIH Device Record Key | e610ac0b-d177-4634-86cf-631bf39c095f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BIOLOX® OPTION |
| Version Model Number | 00-8777-040-01 |
| Catalog Number | 00-8777-040-01 |
| 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 | 40 Millimeter |
| Device Size Text, specify | 0 |
| Length | -3 Millimeter |
| Outer Diameter | 40 Millimeter |
| Device Size Text, specify | 0 |
| Length | -3 Millimeter |
| Outer Diameter | 40 Millimeter |
| Device Size Text, specify | 0 |
| Length | -3 Millimeter |
| Outer Diameter | 40 Millimeter |
| Device Size Text, specify | 0 |
| Length | -3 Millimeter |
| Outer Diameter | 40 Millimeter |
| Device Size Text, specify | 0 |
| Length | -3 Millimeter |
| Outer Diameter | 40 Millimeter |
| Device Size Text, specify | 0 |
| Length | -3 Millimeter |
| Outer Diameter | 40 Millimeter |
| Device Size Text, specify | 0 |
| Length | -3 Millimeter |
| Outer Diameter | 40 Millimeter |
| Device Size Text, specify | 0 |
| Length | -3 Millimeter |
| Outer Diameter | 40 Millimeter |
| Device Size Text, specify | 0 |
| Length | -3 Millimeter |
| Outer Diameter | 40 Millimeter |
| Device Size Text, specify | 0 |
| Length | -3 Millimeter |
| Outer Diameter | 40 Millimeter |
| Device Size Text, specify | 0 |
| Length | -3 Millimeter |
| Outer Diameter | 40 Millimeter |
| Device Size Text, specify | 0 |
| Length | -3 Millimeter |
| Outer Diameter | 40 Millimeter |
| Device Size Text, specify | 0 |
| Length | -3 Millimeter |
| Outer Diameter | 40 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 | 00889024430556 [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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.