BUECHEL-PAPPAS HUMERAL STEM COMPONENT
FDA 510(k) clearance K904880 · decided 1991-01-28
Clearance details
- K-number
- K904880
- Device name
- BUECHEL-PAPPAS HUMERAL STEM COMPONENT
- Applicant
- Endotec, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-10-30
- Decision date
- 1991-01-28
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- KWS
- Device class
- 2
- Regulation number
- 888.3660
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- South Orange, NJ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Endotec
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.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Endotec Prosthesis Shoulder, Titanium Alloy, Sterilized Modular Femoral Stem BP Shoulder C recall (Z-1622-2010) | Endotec, Inc. | 2010-05-20 |