IMPLANT, HINGE TOE, FLEX.
FDA 510(k) clearance K780132 · decided 1978-02-06
Clearance details
- K-number
- K780132
- Device name
- IMPLANT, HINGE TOE, FLEX.
- Applicant
- Dow Corning Corp. Healthcare Industries Materials
- Decision
- Substantially Equivalent
- Date received
- 1978-01-24
- Decision date
- 1978-02-06
- Days to decision
- 13 days
- Clearance type
- Traditional
- Product code
- KWH
- Device class
- 2
- Regulation number
- 888.3720
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Walker, MI, 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 |
|---|---|---|
| NewPrim System (K191966) | Brm Extremities | 2020-02-13 |
| Fusion Silastic System (K190136) | Fusion Orthopedics, LLC | 2019-10-21 |
| RTS Lesser MTP Implant System (K173491) | In2bones USA, LLC | 2018-02-23 |
| RTS Flexible 1 MPJ Implant w/Grommets (K153609) | In2bones USA, LLC | 2016-09-08 |
| ORTHOFLEX ROD (K102601) | Ortho-Pro, LLC | 2011-01-14 |
| LESSER METATARSAL PHALANGEAL JOINT IMPLANT (K023531) | Nexa Orthopedics, Inc. | 2003-01-17 |
| INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM (K022887) | Osteomed Corp. | 2002-11-26 |
| METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM (K022886) | Osteomed Corp. | 2002-11-25 |
| MODIFICATION TO CLASSIC GREAT TOE IMPLANT (K023562) | Nexa Orthopedics, Inc. | 2002-11-13 |
| CLASSIC GREAT TOE IMPLANT (K023086) | Nexa Orthopedics, Inc. | 2002-10-04 |
| ASCENT KNEE SYSTEM (K994326) | Biomet Manufacturing, Inc. | 2000-01-07 |
| FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANT (K981194) | Nexa Orthopedics, Inc. | 1998-06-30 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| THE SOFT RINSE SYSTEM (P800060/S007) | Dow Corning Corp. Healthcare Industries Materials | 1991-03-05 |
| SILCON(R) (SILAFILCON A) CONTACT LENS DAILY WEAR (P800054/S010) | Dow Corning Corp. Healthcare Industries Materials | 1985-11-18 |
| SILSOFT (ELASTOFILCON A ) CONTACT LENS (P800020/S007) | Dow Corning Corp. Healthcare Industries Materials | 1985-11-05 |
| THE SOFT RINSE SYSTEM (P800060/S006) | Dow Corning Corp. Healthcare Industries Materials | 1985-07-30 |
| SILCON(R) (SILAFILCON A) CONTACT LENS DAILY WEAR (P800054/S008) | Dow Corning Corp. Healthcare Industries Materials | 1984-10-31 |
| THE SOFT RINSE SYSTEM (P800060/S005) | Dow Corning Corp. Healthcare Industries Materials | 1984-04-04 |
| SILCON(R) (SILAFILCON A) CONTACT LENS DAILY WEAR (P800054/S009) | Dow Corning Corp. Healthcare Industries Materials | 1984-03-12 |
| SILCON(R) (SILAFILCON A) CONTACT LENS DAILY WEAR (P800054/S004) | Dow Corning Corp. Healthcare Industries Materials | 1983-11-09 |