510(k) K790793
- Device
- AMC R METACARPAL COMPONENT
- Applicant
- HOWMEDICA CORP.
- 510(k) number
- K790793
- Product code
- KWN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-06-22
- Date received
- 1979-04-24
- Regulation
- 888.3750
- Classification name
- Prosthesis, Wrist, Carpal Lunate
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 1649833
- 3004154314
- 3010667733
- 1043534
- 3014207283
- 1649379
- 1450662
- 1828288
- 1825034
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KWN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K141920 | Wrist Hemiarthroplasty System | Arthrosurface, Inc. | 2014-12-23 |
| 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 |
Legacy Summary#
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FDA Review#
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