GLADIATOR BIPOLAR SYSTEM
FDA 510(k) clearance K062693 · decided 2006-09-29
Clearance details
- K-number
- K062693
- Device name
- GLADIATOR BIPOLAR SYSTEM
- Applicant
- Wrightmedicaltechnologyinc
- Decision
- Substantially Equivalent
- Date received
- 2006-09-11
- Decision date
- 2006-09-29
- Days to decision
- 18 days
- Clearance type
- Special
- Product code
- KWY
- Device class
- 2
- Regulation number
- 888.3390
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Arlington, TN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-2241, Size 41mm O.D recall (Z-0567-2007) | Wright Medical Technology Inc | 2007-03-07 |
| Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3650, Size 50mm O.D recall (Z-0568-2007) | Wright Medical Technology Inc | 2007-03-07 |
| Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3651, Size 51mm O.D recall (Z-0569-2007) | Wright Medical Technology Inc | 2007-03-07 |
| Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3652, Size 52mm O.D recall (Z-0570-2007) | Wright Medical Technology Inc | 2007-03-07 |
| Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3653, Size 53mm O.D recall (Z-0571-2007) | Wright Medical Technology Inc | 2007-03-07 |
| Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3654, Size 54mm O.D recall (Z-0572-2007) | Wright Medical Technology Inc | 2007-03-07 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ADCON(R)-L ADHESION CONTROL IN A BARRIER GEL (P960057/S011) | Wrightmedicaltechnologyinc | 2000-09-27 |
| ADCON-L ADHESION CONTROL IN A BARRIER GEL (P960057/S004) | Wrightmedicaltechnologyinc | 1999-08-11 |
| ADCON-L ADHESION CONTROL IN A BARRIER GEL (P960057/S008) | Wrightmedicaltechnologyinc | 1999-06-02 |
| ADCON-L ADHESION CONTROL IN A BARRIER GEL (P960057/S006) | Wrightmedicaltechnologyinc | 1999-04-21 |
| ADCON-L ADHESION CONTROL IN A BARRIER GEL (P960057/S005) | Wrightmedicaltechnologyinc | 1999-03-18 |
| ADCON -L ADHESION CONTROL IN A BARRIER GEL (P960057/S003) | Wrightmedicaltechnologyinc | 1999-01-14 |
| ADCON -L ADHESION CONTROL IN A BARRIER GEL (P960057/S002) | Wrightmedicaltechnologyinc | 1998-11-25 |
| ADCON-L ANTI-ADHESION CONTROL IN A BARRIER GEL (P960057/S001) | Wrightmedicaltechnologyinc | 1998-09-11 |