510(k) K141920
- Device
- Wrist Hemiarthroplasty System
- Applicant
- ARTHROSURFACE, INC.
- 510(k) number
- K141920
- Product code
- KWN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-12-23
- Date received
- 2014-07-16
- Regulation
- 888.3750
- Classification name
- Prosthesis, Wrist, Carpal Lunate
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAWN J WILSON
- Address
- 28 Forge Pkwy. Franklin MA US 02038 02038
FDA Registration Numbers#
- 1649833
- 3004154314
- 3010667733
- 1043534
- 3014207283
- 1649379
- 1450662
- 1828288
- 1825034
Source Documents#
Other 510(k) Records For Product Code KWN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K080997 | ASCENSION PYROCARBON LUNATE | Ascension Orthopedics, Inc. | 2008-06-17 |
| K050028 | MAESTRO CARPAL HEMIARTHROPLASTY | Biomet Manufacturing, Inc. | 2005-03-25 |
| K864491 | SWANSON TITANIUM CARPAL LUNATE IMPLANT | Dow Corning Wright | 1987-04-15 |
| K790793 | AMC R METACARPAL COMPONENT | Howmedica Corp. | 1979-06-22 |
Legacy Summary#
summary
FDA Review#
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