510(k) K983766 ยท EZX Mesh, Surgical, Metal
SYNTHES SYNMESH
| Applicant | Synthes (Usa), Paoli PA, US |
| Decision | Substantially Equivalent, Dec 18, 1998 |
| Received | Oct 26, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983766
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 21, 2020 | Synthes (USA) Products LLC DePuy Synthes SYNMESH 10MM DIA 18MM HEIGHT (TI)
Product Number: 495.344 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in variou Terminated |
MQP | None listed |
| Sep 21, 2020 | Synthes (USA) Products LLC SYNMESH 12MM DIA 88MM HEIGHT (TI)
Product Number: 495.357 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints Terminated |
MQP | None listed |
| Sep 21, 2020 | Synthes (USA) Products LLC SYNMESH 15MM DIA 88MM HEIGHT (TI)
Product Number: 495.366 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints Terminated |
MQP | None listed |
| Sep 21, 2020 | Synthes (USA) Products LLC SYNMESH 17MM X 22MM 88MM HEIGHT (TI)
Product Number: 495-374 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprin Terminated |
MQP | None listed |
| Sep 21, 2020 | Synthes (USA) Products LLC SYNMESH 22MM X 28MM 88MM HEIGHT (TI)
Product Number: 495.379 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprin Terminated |
MQP | None listed |
| Sep 21, 2020 | Synthes (USA) Products LLC END RING 10MM DIA/0 DEG (TI) Product Number: 495.384 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and h Terminated |
MQP | None listed |
| Sep 21, 2020 | Synthes (USA) Products LLC END RING 12MM DIA/0 DEG (TI) Product Number: 495.385 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and h Terminated |
MQP | None listed |
| Sep 21, 2020 | Synthes (USA) Products LLC END RING 15MM DIA/0 DEG (TI) Product Number: 495.386 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and h Terminated |
MQP | None listed |
| Sep 21, 2020 | Synthes (USA) Products LLC END RING 17MM X 22MM LATERAL OR ANTERIOR/0 DEG (TI)
Product Number: 495.392 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in v Terminated |
MQP | None listed |
| Sep 21, 2020 | Synthes (USA) Products LLC END RING 17MM X 22MM LATERAL OR ANTERIOR/5 DEG (TI)
Product Number: 495.394 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in v Terminated |
MQP | None listed |
| Sep 21, 2020 | Synthes (USA) Products LLC END RING 22MM X 28MM LATERAL OR ANTERIOR/0 DEG (TI)
Product Number: 495-396 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in v Terminated |
MQP | None listed |
| Sep 21, 2020 | Synthes (USA) Products LLC END RING 22MM X 28MM LATERAL OR ANTERIOR/5 DEG (TI)
Product Number: 495-398 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in v Terminated |
MQP | None listed |
| Sep 21, 2020 | Synthes (USA) Products LLC STANDARD RING 17MM X 22MM (TI) Product Number: 495-405 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and Terminated |
MQP | None listed |
| Sep 21, 2020 | Synthes (USA) Products LLC STANDARD RING 22MM X 28MM (TI) Product Number: 495-406 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and Terminated |
MQP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.