510(k) K183550 · NKB Thoracolumbosacral Pedicle Screw System
Vitality® Spinal Fixation System
| Applicant | Zimmer Biomet Spine, Inc., Westminister CO, US |
| Decision | Substantially Equivalent, Apr 8, 2019 |
| Received | Dec 20, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183550
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 5, 2020 | Zimmer Biomet, Inc. Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X30MM, Item Number 810M4530 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, post Terminated |
NKB | None listed |
| May 5, 2020 | Zimmer Biomet, Inc. Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X35MM, Item Number 810M4535 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, post Terminated |
NKB | None listed |
| May 5, 2020 | Zimmer Biomet, Inc. Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X40MM, Item Number 810M4540 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, post Terminated |
NKB | None listed |
| May 5, 2020 | Zimmer Biomet, Inc. Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X35MM, Item Number 810M5535 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, post Terminated |
NKB | None listed |
| May 5, 2020 | Zimmer Biomet, Inc. Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X45MM, Item Number 810M5545 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, post Terminated |
NKB | None listed |
| May 5, 2020 | Zimmer Biomet, Inc. Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X50MM, Item Number 810M5550 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, post Terminated |
NKB | None listed |
| May 5, 2020 | Zimmer Biomet, Inc. Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X55MM, Item Number 810M5555 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, post Terminated |
NKB | None listed |
| May 5, 2020 | Zimmer Biomet, Inc. Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X35MM, Item Number 810M6535 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, post Terminated |
NKB | None listed |
| May 5, 2020 | Zimmer Biomet, Inc. Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X45MM, Item Number 810M6545 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, post Terminated |
NKB | None listed |
| May 5, 2020 | Zimmer Biomet, Inc. Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X50MM, Item Number 810M6550 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, post Terminated |
NKB | None listed |
| May 5, 2020 | Zimmer Biomet, Inc. Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X55MM, Item Number 810M6555 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, post Terminated |
NKB | None listed |
| May 5, 2020 | Zimmer Biomet, Inc. Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X35MM, Item Number 810M7535 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, post Terminated |
NKB | None listed |
| May 5, 2020 | Zimmer Biomet, Inc. Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X40MM, Item Number 810M6540 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, post Terminated |
NKB | None listed |
| May 5, 2020 | Zimmer Biomet, Inc. Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X45MM, Item Number 810M7545 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, post Terminated |
NKB | None listed |
| May 5, 2020 | Zimmer Biomet, Inc. Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X50MM, Item Number 810M7550 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, post Terminated |
NKB | None listed |
| May 5, 2020 | Zimmer Biomet, Inc. Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X55MM, Item Number 810M7555 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, post Terminated |
NKB | None listed |
| May 5, 2020 | Zimmer Biomet, Inc. Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X40MM, Item Number 811M8540 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, poste Terminated |
NKB | None listed |
| May 5, 2020 | Zimmer Biomet, Inc. Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X45MM, Item Number 811M8545 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, poste Terminated |
NKB | None listed |
| May 5, 2020 | Zimmer Biomet, Inc. Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X50MM, Item Number 811M8550 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, poste Terminated |
NKB | None listed |
| May 5, 2020 | Zimmer Biomet, Inc. Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X55MM, Item Number 811M8555 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, poste Terminated |
NKB | None listed |
| May 5, 2020 | Zimmer Biomet, Inc. Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X60MM, Item Number 811M8560 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, poste Terminated |
NKB | None listed |
| May 5, 2020 | Zimmer Biomet, Inc. Vital MIS Spinal Fixation system implants VITAL MIS TAB BREAKER, Item Number 850M0055 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior Terminated |
LXH | None listed |
| May 5, 2020 | Zimmer Biomet, Inc. Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X40MM, Item Number 810M7540 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, post Terminated |
NKB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.