SILASTIC HEMI WRIST IMPLANT H.P. (RAD.)
FDA 510(k) clearance K812053 · decided 1981-08-18
Clearance details
- K-number
- K812053
- Device name
- SILASTIC HEMI WRIST IMPLANT H.P. (RAD.)
- Applicant
- Dow Corning Corp. Healthcare Industries Materials
- Decision
- Substantially Equivalent
- Date received
- 1981-07-21
- Decision date
- 1981-08-18
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- KXE
- Device class
- 2
- Regulation number
- 888.3810
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Mchenry, IL, 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 |
|---|---|---|
| Aptis Medical Distal Radio Ulnar Joint Implant (K190599) | Aptis Medical, LLC | 2019-05-03 |
| Aptis Medical Distal Radio Ulnar Joint Implant (K142569) | Aptis Medical, LLC | 2015-04-03 |
| FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT (K112481) | Ascension Orthopedic | 2012-04-09 |
| ISOELASTICU (K081025) | Remi Sciences, Inc. | 2008-11-21 |
| DISTAL RADIO-ULNAR JOINT IMPLANT (K082839) | Aptis Medical, LLC | 2008-10-24 |
| SBI ULNAR HEAD IMPLANT (K061146) | Small Bone Innovations, Inc. | 2006-07-19 |
| DISTAL RADIO-ULNAR JOINT IMPLANT (K053119) | Aptis Medical, LLC | 2005-12-07 |
| ASCENSION MUH (K052137) | Ascension Orthopedics, Inc. | 2005-11-03 |
| DISTAL RADIO-ULNAR JOINT IMPLANT (K040497) | Aptis Medical, LLC | 2005-01-26 |
| HERBERT ULNAR HEAD PROSTHESIS SYSTEM (K042902) | Stuckenbrock Medizintechnik GmbH | 2004-12-27 |
| KAPP CUSTOM ULNAR HEAD WRIST IMPLANT (K033930) | Kapp Surgical Instrument, Inc. | 2004-07-28 |
| WMT MODULAR ULNAR HEAD IMPLANT (K020274) | Wrightmedicaltechnologyinc | 2002-02-22 |
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 |