3M OSTEOTOMY GUIDE
FDA 510(k) clearance K830360 · decided 1983-03-01
Clearance details
- K-number
- K830360
- Device name
- 3M OSTEOTOMY GUIDE
- Applicant
- 3M Company
- Decision
- Substantially Equivalent
- Date received
- 1983-02-03
- Decision date
- 1983-03-01
- Days to decision
- 26 days
- Clearance type
- Traditional
- Product code
- HWT
- Device class
- 1
- Regulation number
- 888.4800
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- White City, OR, 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 |
|---|---|---|
| ORTHOPLAN (K974406) | Ortho-Graphics, Inc. | 1998-02-18 |
| 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 |
| 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.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S011) | 3M Company | 1994-11-28 |
| CENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S010) | 3M Company | 1994-05-19 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S006) | 3M Company | 1992-12-31 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S009) | 3M Company | 1992-03-13 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S008) | 3M Company | 1992-01-28 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S007) | 3M Company | 1990-10-17 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S005) | 3M Company | 1990-03-08 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S004) | 3M Company | 1989-11-22 |