Product code HWJ
- Device name
- Awl
- 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 |
|---|---|---|---|
| K895587 | CROSS MEDICAL PRODUCT PEDICLE AWL | Cross Medical Products, Inc. | 1990-01-04 |
| K875223 | DANNINGER ORTHOPAEDIC AWL | Danninger Medical Technology, Inc. | 1988-02-17 |
| K880045 | ACROMED AWL/PUNCH, DEPTH GAUGE | Buckman Co., Inc. | 1988-02-17 |
| K870779 | ACROMED WALLIE-HEINIG TROCHAR | Buckman Co., Inc. | 1987-03-09 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07640375234773 | SCARLET AL-T INSTRUMENTATION | SpineArt SA | 2025-11-10 |
| 08059386744338 | Orthopaedic Surgical Instruments | CITIEFFE SRL | 2025-11-06 |
| 09120129291507 | Awl, Curved, Cannulated | I.T.S. GmbH | 2025-10-21 |
| 09120129291514 | Awl Trocar | I.T.S. GmbH | 2025-10-21 |
| 08800068948533 | LOSPA IS Spinal System | Corentec Co., Ltd | 2022-10-18 |
| G079C5020010070 | Golden Isles Pedicle Screw System | Intelivation, LLC | 2022-09-23 |
| 10381780407416 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-05-03 |
| 10381780407409 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-05-03 |
| 10381780407393 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-05-03 |
| 10381780282457 | Integra® PyroCarbon | Ascension Orthopedics, Inc. | 2018-04-13 |
| 10381780279662 | Katalyst™ Bipolar Radial Head System | Ascension Orthopedics, Inc. | 2018-04-10 |
| 10381780278771 | Universal 2™ Total Wrist Implant System | Ascension Orthopedics, Inc. | 2018-03-09 |
| 10381780185406 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-01-31 |
| 10381780424406 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-01-10 |
| 10381780424390 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-01-10 |
| 10381780424383 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-01-10 |
| 10381780212799 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-10-31 |
| 10381780242161 | Integra® | Ascension Orthopedics, Inc. | 2017-09-05 |
| 10381780242147 | Titan™ | Ascension Orthopedics, Inc. | 2017-09-05 |
| 10381780242178 | Integra® | Ascension Orthopedics, Inc. | 2017-09-05 |
| 10381780242154 | Integra® | Ascension Orthopedics, Inc. | 2017-09-05 |
| 10381780212805 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2017-06-27 |
| 10381780051466 | PANTA® | NEWDEAL | 2017-05-26 |
| 10705034700830 | ANTEGRA-T | Synthes GmbH | 2016-12-31 |
| 10705034700960 | NA | Synthes GmbH | 2016-12-31 |
| 10705034700977 | NA | Synthes GmbH | 2016-12-31 |
| 10705034701042 | NA | Synthes GmbH | 2016-12-31 |
| 10705034702094 | NA | Synthes GmbH | 2016-12-31 |
| 10705034702100 | NA | Synthes GmbH | 2016-12-31 |
| 10705034703657 | NA | Synthes GmbH | 2016-12-31 |