OSTEOSET DBM PELLETS
FDA 510(k) clearance K053642 · decided 2006-01-26
Clearance details
- K-number
- K053642
- Device name
- OSTEOSET DBM PELLETS
- Applicant
- Wrightmedicaltechnologyinc
- Decision
- Substantially Equivalent
- Date received
- 2005-12-30
- Decision date
- 2006-01-26
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- MBP
- Device class
- 2
- Regulation number
- 888.3045
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Arlington, TN, US
- Third-party review
- No
- Expedited review
- No
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| ACCELL EVO3 (FORMERLY ACCELL A2I) (K103742) | Integra Life Sciences | 2011-03-17 |
| ACCELL EVO3C (K091193) | Isotis Orthobiologics, Inc. | 2009-08-10 |
| DBX DEMINERALIZED BONE MATRIX PUTTY, DBX DEMINERALIZED BONE MATRIX PASTE (K080399) | Musculoskeletal Transplant Foundation | 2008-10-10 |
| ACCELL TBM-R (K081817) | Isotis Orthobiologics, Inc. | 2008-09-24 |
| SYGNAL DBM (K080405) | Musculoskeletal Transplant Foundation | 2008-08-28 |
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Recalls involving this device
No recalls on record reference this clearance.
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 |