510(k) K142569
- Device
- Aptis Medical Distal Radio Ulnar Joint Implant
- Applicant
- APTIS MEDICAL, LLC.
- 510(k) number
- K142569
- Product code
- KXE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-04-03
- Date received
- 2014-09-12
- Regulation
- 888.3810
- Classification name
- Prosthesis, Wrist, Hemi-, Ulnar
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Bryann Babb
- Address
- 3602 Glenview Ave. Glenview KY US 40025 40025
FDA Registration Numbers#
- 8031020
- 3003477135
- 3003387384
- 1828288
- 3013023969
- 3014207283
- 1834331
- 2531477
- 2183946
- 3004521401
- 1226544
- 2183319
- 3009241418
- 1649379
- 1522875
- 2030624
- 2032521
- 1649518
Source Documents#
Other 510(k) Records For Product Code KXE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K190599 | Aptis Medical Distal Radio Ulnar Joint Implant | Aptis Medical, LLC | 2019-05-03 |
| K112481 | FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT | Ascension Orthopedic | 2012-04-09 |
| K081025 | ISOELASTICU | Remi Sciences, Inc. | 2008-11-21 |
| K082839 | DISTAL RADIO-ULNAR JOINT IMPLANT | Aptis Medical, LLC | 2008-10-24 |
| K061146 | SBI ULNAR HEAD IMPLANT | Small Bone Innovations, Inc. | 2006-07-19 |
| K053119 | DISTAL RADIO-ULNAR JOINT IMPLANT | Aptis Medical, LLC | 2005-12-07 |
| K052137 | ASCENSION MUH | Ascension Orthopedics, Inc. | 2005-11-03 |
| K040497 | DISTAL RADIO-ULNAR JOINT IMPLANT | Aptis Medical, LLC | 2005-01-26 |
| K042902 | HERBERT ULNAR HEAD PROSTHESIS SYSTEM | Stuckenbrock Medizintechnik GmbH | 2004-12-27 |
| K033930 | KAPP CUSTOM ULNAR HEAD WRIST IMPLANT | Kapp Surgical Instrument, Inc. | 2004-07-28 |
| K020274 | WMT MODULAR ULNAR HEAD IMPLANT | Wrightmedicaltechnologyinc | 2002-02-22 |
| K010786 | ULNAR HEAD IMPLANT | Avanta Orthopaedics, Inc. | 2001-04-11 |
| K982268 | ULNAR HEAD IMPLANT | Avanta Orthopaedics, Inc. | 1998-12-04 |
| K812053 | SILASTIC HEMI WRIST IMPLANT H.P. (RAD.) | Dow Corning Corp. Healthcare Industries Materials | 1981-08-18 |
| K790125 | ULNAR HEAD PROTHESIS | Cutter Laboratories, Inc. | 1979-02-08 |
Legacy Summary#
summary
FDA Review#
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