510(k) K081149 ยท HWC Screw, Fixation, Bone
BIOPRO GO-EZ SCREW
| Applicant | Biopro, Inc., Port Huron MI, US |
| Decision | Substantially Equivalent, Aug 5, 2008 |
| Received | Apr 22, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081149
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 25, 2019 | BioPro, Inc. K-Wire Sterile Single Trochar, Item Number 19106 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but Terminated |
NBH | None listed |
| Jun 25, 2019 | BioPro, Inc. K-Wire Sterile Single Trochar .045, Item Number 19108 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures Terminated |
NBH | None listed |
| Jun 25, 2019 | BioPro, Inc. Go-EZ Screw 6.5x30, Item Number 19651 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not inte Terminated |
NBH | None listed |
| Jun 25, 2019 | BioPro, Inc. Go-EZ Screw 6.5x100, Item Number 19668 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not int Terminated |
NBH | None listed |
| Jun 25, 2019 | BioPro, Inc. Go-EZ Screw 6.5x36, Item Number 19654 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not inte Terminated |
NBH | None listed |
| Jun 25, 2019 | BioPro, Inc. Go-EZ Screw 6.5x95, Item Number 19667 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not inte Terminated |
NBH | None listed |
| Jun 25, 2019 | BioPro, Inc. Go-EZ Screw 6.5x34, Item Number 19653 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not inte Terminated |
NBH | None listed |
| Jun 25, 2019 | BioPro, Inc. Go-EZ Screw 6.5x85, Item Number 19665 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not inte Terminated |
NBH | None listed |
| Jun 25, 2019 | BioPro, Inc. Go-EZ Screw 6.5x90, Item Number 19666 - Product Usage:Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not inten Terminated |
NBH | None listed |
| Jun 25, 2019 | BioPro, Inc. Go-EZ Screw 6.5x115, Item Number 19671 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not int Terminated |
NBH | None listed |
| Jun 25, 2019 | BioPro, Inc. Go-EZ Screw 6.5x32, Item Number 19652 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not inte Terminated |
NBH | None listed |
| Jun 25, 2019 | BioPro, Inc. Go-EZ Screw 6.5x105, Item Number 19669 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not int Terminated |
NBH | None listed |
| Jun 25, 2019 | BioPro, Inc. Go-EZ Screw 6.5x110, Item Number 19670 - Product Usage:Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not inte Terminated |
NBH | None listed |
| Jun 25, 2019 | BioPro, Inc. Go-EZ Screw 6.5x120, Item Number 19672 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not int Terminated |
NBH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.