ROTH-KENNEDY PASSER
FDA 510(k) clearance K791960 · decided 1979-10-04
Clearance details
- K-number
- K791960
- Device name
- ROTH-KENNEDY PASSER
- Applicant
- 3M Company
- Decision
- Substantially Equivalent
- Date received
- 1979-10-01
- Decision date
- 1979-10-04
- Days to decision
- 3 days
- Clearance type
- Traditional
- Product code
- HWQ
- Device class
- 1
- Regulation number
- 888.4540
- 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 |
|---|---|---|
| MITEK SUTURE RETROGRADER (K970360) | Mitek Products | 1997-03-10 |
| SOFT TISSUE EXPANDER (K923381) | Acufex Microsurgical, Inc. | 1993-05-05 |
| ACUFEX PASSING PINS AND SURGICAL WIRE (K920621) | Acufex Microsurgical, Inc. | 1993-05-05 |
| MENISCUS MENDER II LOOP (K885311) | Instrument Makar, Inc. | 1989-02-09 |
| VICO MICRO SURGICAL INSTRUMENTS (K843592) | Visitec Co. | 1984-10-05 |
| SOFT-TISSUE INSTRUMENT (K841622) | Plastafil, Inc. | 1984-07-11 |
| SLOTTED SOFT-TISSUE INSTRUMENT (K841623) | Plastafil, Inc. | 1984-07-11 |
| SILASTIC TENDON PASSER H.P. (K811679) | Dow Corning Corp. Healthcare Industries Materials | 1981-07-10 |
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 |