ORTHOPLAN
FDA 510(k) clearance K974406 · decided 1998-02-18
Clearance details
- K-number
- K974406
- Device name
- ORTHOPLAN
- Applicant
- Ortho-Graphics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-11-21
- Decision date
- 1998-02-18
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- HWT
- Device class
- 1
- Regulation number
- 888.4800
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Saltlake, UT, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ORTHODOC PREOPERATIVE PLANNER MODEL 500 (K960685) | Integrated Surgical Systems, Inc. | 1997-01-17 |
| KRONNER SPHERICAL CUTTERS (K894228) | Kronner Medical | 1990-07-23 |
| SCHULTZ PHALANGEAL COMP TRIAL/METACARPAL COMP TRIA (K870843) | Warsaw Orthopedic, Inc. | 1987-05-27 |
| ARTHROSCOPIC MENISCAL SUTURE SYSTEM (K871323) | Orthopedic Systems, Inc. | 1987-05-01 |
| 3M OSTEOTOMY GUIDE (K830360) | 3M Company | 1983-03-01 |
| MOLDED POLYSULFONE TRIAL PROSTHESIS (K811205) | Shannon Group | 1981-05-21 |
| KNEE INSTRUMENTATION, CONDYLAR (K781091) | Biomet, Inc. | 1978-07-17 |
| WORRELL TRIAL PATELLA (K771709) | Depuy, Inc. | 1977-10-06 |
| WORRELL PATELLA TEMPLATE (K771710) | Depuy, Inc. | 1977-10-06 |
Recalls involving this device
No recalls on record reference this clearance.