AMC R METACARPAL COMPONENT
FDA 510(k) clearance K790793 · decided 1979-06-22
Clearance details
- K-number
- K790793
- Device name
- AMC R METACARPAL COMPONENT
- Applicant
- Howmedica Corp.
- Decision
- Substantially Equivalent
- Date received
- 1979-04-24
- Decision date
- 1979-06-22
- Days to decision
- 59 days
- Clearance type
- Traditional
- Product code
- KWN
- Device class
- 2
- Regulation number
- 888.3750
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Howmedica Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Wrist Hemiarthroplasty System (K141920) | Arthrosurface, Inc. | 2014-12-23 |
| ASCENSION PYROCARBON LUNATE (K080997) | Ascension Orthopedics, Inc. | 2008-06-17 |
| MAESTRO CARPAL HEMIARTHROPLASTY (K050028) | Biomet Manufacturing, Inc. | 2005-03-25 |
| SWANSON TITANIUM CARPAL LUNATE IMPLANT (K864491) | Dow Corning Wright | 1987-04-15 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SURGICAL SIMPLEX P BONE CEMENT (N17004/S013) | Howmedica Corp. | 2000-12-15 |
| SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT (N17004/S012) | Howmedica Corp. | 2000-06-20 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S011) | Howmedica Corp. | 1998-03-18 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S010) | Howmedica Corp. | 1997-11-13 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S009) | Howmedica Corp. | 1997-08-08 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S008) | Howmedica Corp. | 1996-12-18 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S005) | Howmedica Corp. | 1995-11-21 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S006) | Howmedica Corp. | 1995-02-24 |