MODULAR PLUS HIP STEM
FDA 510(k) clearance K032709 · decided 2003-09-23
Clearance details
- K-number
- K032709
- Device name
- MODULAR PLUS HIP STEM
- Applicant
- Plus Orthopedics
- Decision
- Substantially Equivalent
- Date received
- 2003-09-02
- Decision date
- 2003-09-23
- Days to decision
- 21 days
- Clearance type
- Special
- Product code
- LWJ
- Device class
- 2
- Regulation number
- 888.3360
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Round Rock, TX, US
- Third-party review
- No
- Expedited review
- No
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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.