Product code HXP
- Device name
- Instrument, Bending Or Contouring
- 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 |
|---|---|---|---|
| K872858 | WILLIAMS VERTEBRAL SPREADER | Ace Medical Co. | 1987-10-15 |
| K800730 | RETROGRADE KNIFE | Stainless Mfg., Inc. | 1980-04-08 |
| K800731 | MENISCAL SAW | Stainless Mfg., Inc. | 1980-04-08 |
| K800732 | MENISCOTOME | Stainless Mfg., Inc. | 1980-04-08 |
| K800733 | DOUBLE-EDGE CURETTE | Stainless Mfg., Inc. | 1980-04-08 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07640187461572 | Bending Iron | Bonebridge AG | 2022-12-23 |
| 10886982191731 | NA | Synthes GmbH | 2018-07-18 |
| 10886982191717 | NA | Synthes GmbH | 2018-07-18 |
| 10886982191724 | NA | Synthes GmbH | 2017-10-12 |
| 10886982075451 | NA | Synthes GmbH | 2017-10-12 |
| 10886982075444 | NA | Synthes GmbH | 2017-10-12 |
| 10886982070999 | NA | Synthes GmbH | 2017-10-12 |
| 10886982070982 | NA | Synthes GmbH | 2017-10-12 |
| 10886982070975 | NA | Synthes GmbH | 2017-10-12 |
| M209206620 | Holding and Bending Pins 2.0 | BIOPRO, INC. | 2017-08-13 |
| M209206630 | Holding and Bending Pins 2.5 – 2.8mm | BIOPRO, INC. | 2017-08-13 |
| M209206640 | Bending Iron left | BIOPRO, INC. | 2017-08-13 |
| M209206650 | Bending Iron right | BIOPRO, INC. | 2017-08-13 |
| M209207390 | Holding and Bending Pin 3.0-3.5-4.0mm | BIOPRO, INC. | 2017-08-13 |
| 10886982073006 | LCP | Synthes GmbH | 2016-12-31 |
| 10886982075635 | NA | Synthes GmbH | 2016-12-31 |
| 10705034771618 | NA | Synthes GmbH | 2016-12-31 |
| 10886982075420 | NA | Synthes GmbH | 2016-12-31 |
| 10886982075383 | NA | Synthes GmbH | 2016-12-31 |
| 10886982075307 | NA | Synthes GmbH | 2016-12-31 |
| 10705034773926 | NA | Synthes GmbH | 2016-12-31 |
| 10886982071002 | NA | Synthes GmbH | 2016-12-31 |
| 10705034771915 | NA | Synthes GmbH | 2016-12-31 |
| 10705034771922 | NA | Synthes GmbH | 2016-12-31 |
| 10705034773919 | NA | Synthes GmbH | 2016-12-31 |
| 10886982070807 | NA | Synthes GmbH | 2016-12-31 |
| 10886982005397 | NA | Synthes GmbH | 2016-12-31 |
| 10886982005366 | NA | Synthes GmbH | 2016-12-31 |
| 10705034775845 | NA | Synthes GmbH | 2016-12-31 |
| 10810190016326 | ISI Tunnel Notcher | T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION | 2016-09-24 |