PERFECTA REVISION HIP SYSTEM
FDA 510(k) clearance K955553 · decided 1996-10-24
Clearance details
- K-number
- K955553
- Device name
- PERFECTA REVISION HIP SYSTEM
- Applicant
- Wrightmedicaltechnologyinc
- Decision
- Substantially Equivalent
- Date received
- 1995-12-05
- Decision date
- 1996-10-24
- Days to decision
- 324 days
- Clearance type
- Traditional
- Product code
- LWJ
- Device class
- 2
- Regulation number
- 888.3360
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Arlington, TN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Wrightmedicaltechnologyinc
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.
| Record | Firm | Date |
|---|---|---|
| UNISYN PLUS HIP STEM (K120595) | Consensus Orthopedics, Inc. | 2012-10-12 |
| TRINITY ACETABULAR SYSTEM (K103518) | Corin USA | 2011-03-09 |
| NOVATION CFS PRESS-FIT AND CEMENTED STEMS (K090764) | Exactech, Inc. | 2009-04-21 |
| METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD (K082146) | Aesculap Implant Systems, Inc. | 2008-09-09 |
| 36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT (K070061) | Hayes Medical, Inc. | 2007-01-31 |
| U2 HIP STEM, TI PLASMA SPRAY (K062978) | United Orthopedic Corp. | 2007-01-16 |
| UNISYN HA PLASMA MODULAR HIP (K062383) | Hayes Medical, Inc. | 2006-12-21 |
| EXCIA (K061699) | Aesculap, Inc. | 2006-08-18 |
| BETACONE HIP PROSTHESIS SYSTEM (K051826) | Waldemar Link GmbH & Co. KG | 2005-11-18 |
| U2 ACETABULAR COMPONENT (K050262) | United Orthopedic Corp. | 2005-08-15 |
| EXCIA TOTAL HIP SYSTEM (K042344) | Aesculap, Inc. | 2005-03-16 |
| Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATED (K040685) | Osteoimplant Technology, Inc. | 2005-01-25 |
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 |