EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE SYSTEM
FDA 510(k) clearance K122883 · decided 2013-08-05
Clearance details
- K-number
- K122883
- Device name
- EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE SYSTEM
- Applicant
- Stelkast Company
- Decision
- Substantially Equivalent
- Date received
- 2012-09-20
- Decision date
- 2013-08-05
- Days to decision
- 319 days
- Clearance type
- Traditional
- Product code
- JWH
- Device class
- 2
- Regulation number
- 888.3560
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Mcmurray, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| EXp Tibial Insert ; Intended Use of Device(s): The Proven Gen-Flex Total Knee System is in recall (Z-0970-2015) | Stelkast Co | 2015-01-14 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| STELKAST SURPASS ACETABULAR SYSTEM (P040051/S002) | Stelkast Company | 2011-04-22 |
| STELKAST SURPASS ACETABULAR SYSTEM (P040051/S001) | Stelkast Company | 2009-05-08 |
| STELKAST SURPASS ACETABULAR SYSTEM (P040051) | Stelkast Company | 2006-05-12 |