Product code HTX
- Device name
- Rongeur
- Medical specialty
- Orthopedic
- Device class
- 1
- Regulation number
- 888.4540
- Review panel
- OR
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K874954 | MANUAL RONGEUR | Solway, Inc. | 1987-12-30 |
| K841620 | FRONT RADIUS CUTTER | Plastafil, Inc. | 1984-09-20 |
| K841621 | BACK RADIUS CUTTER | Plastafil, Inc. | 1984-09-20 |
| K780397 | ORTHOPEDIC FORCEPS | Orthopedic Equipment Co., Inc. | 1978-03-22 |
| K760325 | SURGICAL INSTRUMENTS, ORTHOPEDIC | Depuy, Inc. | 1976-08-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00840217903738 | Wiggins Medical | EBNER MEDICAL, LLC | 2021-05-18 |
| 00840217903592 | Wiggins Medical | EBNER MEDICAL, LLC | 2021-05-17 |
| 00840217903721 | Wiggins Medical | EBNER MEDICAL, LLC | 2021-05-17 |
| 00840217903714 | Wiggins Medical | EBNER MEDICAL, LLC | 2021-05-17 |
| 00840217903707 | Wiggins Medical | EBNER MEDICAL, LLC | 2021-05-17 |
| 00840217903691 | Wiggins Medical | EBNER MEDICAL, LLC | 2021-05-17 |
| 00840217903684 | Wiggins Medical | EBNER MEDICAL, LLC | 2021-05-17 |
| 00840217903677 | Wiggins Medical | EBNER MEDICAL, LLC | 2021-05-17 |
| 00840217903660 | Wiggins Medical | EBNER MEDICAL, LLC | 2021-05-17 |
| 00840217903653 | Wiggins Medical | EBNER MEDICAL, LLC | 2021-05-17 |
| 00840217903646 | Wiggins Medical | EBNER MEDICAL, LLC | 2021-05-17 |
| 00840217903639 | Wiggins Medical | EBNER MEDICAL, LLC | 2021-05-17 |
| 00840217903622 | Wiggins Medical | EBNER MEDICAL, LLC | 2021-05-17 |
| 00840217903615 | Wiggins Medical | EBNER MEDICAL, LLC | 2021-05-17 |
| 00840217903608 | Wiggins Medical | EBNER MEDICAL, LLC | 2021-05-17 |
| 00840217903448 | Wiggins Medical | EBNER MEDICAL, LLC | 2021-05-17 |
| 00840217903585 | Wiggins Medical | EBNER MEDICAL, LLC | 2021-05-17 |
| 00840217903578 | Wiggins Medical | EBNER MEDICAL, LLC | 2021-05-17 |
| 00840217903561 | Wiggins Medical | EBNER MEDICAL, LLC | 2021-05-17 |
| 00840217903554 | Wiggins Medical | EBNER MEDICAL, LLC | 2021-05-17 |
| 00840217903547 | Wiggins Medical | EBNER MEDICAL, LLC | 2021-05-17 |
| 00840217903530 | Wiggins Medical | EBNER MEDICAL, LLC | 2021-05-17 |
| 00840217903523 | Wiggins Medical | EBNER MEDICAL, LLC | 2021-05-17 |
| 00840217903516 | Wiggins Medical | EBNER MEDICAL, LLC | 2021-05-17 |
| 00840217903509 | Wiggins Medical | EBNER MEDICAL, LLC | 2021-05-17 |
| 00840217903493 | Wiggins Medical | EBNER MEDICAL, LLC | 2021-05-17 |
| 00840217903486 | Wiggins Medical | EBNER MEDICAL, LLC | 2021-05-17 |
| 00840217903479 | Wiggins Medical | EBNER MEDICAL, LLC | 2021-05-17 |
| 00840217903462 | Wiggins Medical | EBNER MEDICAL, LLC | 2021-05-17 |
| 00840217903455 | Wiggins Medical | EBNER MEDICAL, LLC | 2021-05-17 |