DYNASTY BIOFOAM SHELL
FDA 510(k) clearance K122382 · decided 2012-10-22
Clearance details
- K-number
- K122382
- Device name
- DYNASTY BIOFOAM SHELL
- Applicant
- Wrightmedicaltechnologyinc
- Decision
- Substantially Equivalent
- Date received
- 2012-08-06
- Decision date
- 2012-10-22
- Days to decision
- 77 days
- Clearance type
- Special
- Product code
- MBL
- Device class
- 2
- Regulation number
- 888.3358
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Arlington, TN, US
- Third-party review
- No
- Expedited review
- No
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| R3 XLPE LINERS (K113848) | Smith & Nephew, Inc. | 2012-04-27 |
| R3 XLPE ANTEVERTED LINERS (K102370) | Smith & Nephew, Inc. | 2011-01-19 |
| COCR AND OXINIUM FEMORAL HEADS AND R3 XLPE LINERS (K093363) | Smith & Nephew, Inc. | 2010-01-26 |
| R3 MULTI-HOLE SHELLS AND 36MM XLPE ACETABULAR LINERS (K092386) | Smith & Nephew, Inc. | 2009-11-03 |
| SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEM (K070756) | Smith & Nephew, Inc. | 2007-06-06 |
| REFLECTION 3 ACETABULAR SYSTEM (K061253) | Smith & Nephew, Inc. | 2006-05-31 |
| REFLECTION DUAL DIMENSION SHELL (K960094) | Smith & Nephew Richards, Inc. | 1996-03-27 |
| LOGYK ACETABULAR COMPONENT SYSTEM (K931107) | Arthronics, Inc. | 1994-03-28 |
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 |