HOWMEDICA PRECISION OSTEOLOCK FEMORAL COMPONENT
FDA 510(k) clearance K881983 · decided 1988-10-06
Clearance details
- K-number
- K881983
- Device name
- HOWMEDICA PRECISION OSTEOLOCK FEMORAL COMPONENT
- Applicant
- Howmedica Corp.
- Decision
- Substantially Equivalent
- Date received
- 1988-05-12
- Decision date
- 1988-10-06
- Days to decision
- 147 days
- Clearance type
- Traditional
- Product code
- LWJ
- Device class
- 2
- Regulation number
- 888.3360
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Rutherford, NJ, 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.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SURGICAL SIMPLEX P BONE CEMENT (N17004/S013) | Howmedica Corp. | 2000-12-15 |
| SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT (N17004/S012) | Howmedica Corp. | 2000-06-20 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S011) | Howmedica Corp. | 1998-03-18 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S010) | Howmedica Corp. | 1997-11-13 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S009) | Howmedica Corp. | 1997-08-08 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S008) | Howmedica Corp. | 1996-12-18 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S005) | Howmedica Corp. | 1995-11-21 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S006) | Howmedica Corp. | 1995-02-24 |