Product code HWT
- Device name
- Template
- Medical specialty
- Orthopedic
- Device class
- 1
- Regulation number
- 888.4800
- 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 |
|---|---|---|---|
| K974406 | ORTHOPLAN | Ortho-Graphics, Inc. | 1998-02-18 |
| K960685 | ORTHODOC PREOPERATIVE PLANNER MODEL 500 | Integrated Surgical Systems, Inc. | 1997-01-17 |
| K894228 | KRONNER SPHERICAL CUTTERS | Kronner Medical | 1990-07-23 |
| K870843 | SCHULTZ PHALANGEAL COMP TRIAL/METACARPAL COMP TRIA | Warsaw Orthopedic, Inc. | 1987-05-27 |
| K871323 | ARTHROSCOPIC MENISCAL SUTURE SYSTEM | Orthopedic Systems, Inc. | 1987-05-01 |
| K830360 | 3M OSTEOTOMY GUIDE | 3M Company | 1983-03-01 |
| K811205 | MOLDED POLYSULFONE TRIAL PROSTHESIS | Shannon Group | 1981-05-21 |
| K781091 | KNEE INSTRUMENTATION, CONDYLAR | Biomet, Inc. | 1978-07-17 |
| K771709 | WORRELL TRIAL PATELLA | Depuy, Inc. | 1977-10-06 |
| K771710 | WORRELL PATELLA TEMPLATE | Depuy, Inc. | 1977-10-06 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10885862660541 | AcuMatch | Exactech, Inc. | 2026-05-28 |
| 10885862660558 | AcuMatch | Exactech, Inc. | 2026-05-28 |
| 10885862660565 | AcuMatch | Exactech, Inc. | 2026-05-28 |
| 10885862660527 | AcuMatch | Exactech, Inc. | 2026-05-28 |
| 07613327548716 | Instrument | Howmedica Osteonics Corp. | 2024-02-22 |
| 07613327524550 | INSTRUMENT | Howmedica Osteonics Corp. | 2024-02-22 |
| 07613327524543 | INSTRUMENT | Howmedica Osteonics Corp. | 2024-02-22 |
| 07613327524536 | INSTRUMENT | Howmedica Osteonics Corp. | 2024-02-22 |
| 07613327565850 | INSTRUMENT | Howmedica Osteonics Corp. | 2024-01-08 |
| 07613327459005 | NA | Stryker Leibinger GmbH & Co. KG | 2019-07-17 |
| 07640178982673 | JULIET ® INSTRUMENTATION | SpineArt SA | 2019-01-14 |
| 07640178982741 | JULIET ® INSTRUMENTATION | SpineArt SA | 2019-01-14 |
| 07640178982734 | JULIET ® INSTRUMENTATION | SpineArt SA | 2019-01-14 |
| 07640178982727 | JULIET ® INSTRUMENTATION | SpineArt SA | 2019-01-14 |
| 07640178982710 | JULIET ® INSTRUMENTATION | SpineArt SA | 2019-01-14 |
| 07640178982703 | JULIET ® INSTRUMENTATION | SpineArt SA | 2019-01-14 |
| 07640178982697 | JULIET ® INSTRUMENTATION | SpineArt SA | 2019-01-14 |
| 07640178982680 | JULIET ® INSTRUMENTATION | SpineArt SA | 2019-01-14 |
| 07640178982666 | JULIET ® INSTRUMENTATION | SpineArt SA | 2019-01-14 |
| 07640178982659 | JULIET ® INSTRUMENTATION | SpineArt SA | 2019-01-14 |
| 07640178982642 | JULIET ® INSTRUMENTATION | SpineArt SA | 2019-01-14 |
| 07640178982635 | JULIET ® INSTRUMENTATION | SpineArt SA | 2019-01-14 |
| 07640178982628 | JULIET ® INSTRUMENTATION | SpineArt SA | 2019-01-14 |
| 07640178983212 | TRYPTIK 2 C-PLATE INSTRUMENTATION | SpineArt SA | 2018-08-01 |
| 07640178983229 | TRYPTIK 2 C-PLATE INSTRUMENTATION | SpineArt SA | 2018-08-01 |
| 07640178983236 | TRYPTIK 2 C-PLATE INSTRUMENTATION | SpineArt SA | 2018-08-01 |
| 07640178983243 | TRYPTIK 2 C-PLATE INSTRUMENTATION | SpineArt SA | 2018-08-01 |
| 07640178983250 | TRYPTIK 2 C-PLATE INSTRUMENTATION | SpineArt SA | 2018-08-01 |
| 07640178983267 | TRYPTIK 2 C-PLATE INSTRUMENTATION | SpineArt SA | 2018-08-01 |
| 07640178983274 | TRYPTIK 2 C-PLATE INSTRUMENTATION | SpineArt SA | 2018-08-01 |