Unisyn Ha Plasma Modular Hip
FDA 510(k) K062383 · Hayes Medical, Inc.
510(k) numberK062383
Submission
- Device name
- Unisyn Ha Plasma Modular Hip
- Applicant
- Hayes Medical, Inc.
El Dorado Hills, CA, US - Received
- August 15, 2006
- Decision date
- December 21, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LWJ – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3360
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code LWJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K120595 | Unisyn Plus Hip StemLWJ · Traditional | Consensus Orthopedics, Inc. | 10/12/2012SE |
| K103518 | Trinity Acetabular SystemLWJ · Traditional | Corin USA | 03/09/2011SE |
| K090764 | Novation CFS Press-Fit and Cemented StemsLWJ · Special | Exactech, Inc. | 04/21/2009SE |
| K082146 | Metha Short Stem Hip System XL Femoral HeadLWJ · Special | Aesculap Implant Systems, Inc. | 09/09/2008SE |
| K070061 | 36MM Cocr Femoral Head and 36MM Acetabular InsertLWJ · Special | Hayes Medical, Inc. | 01/31/2007SE |
| K062978 | U2 Hip Stem, Ti Plasma SprayLWJ · Traditional | United Orthopedic Corp. | 01/16/2007SE |
| K061699 | ExciaLWJ · Special | Aesculap, Inc. | 08/18/2006SE |
| K051826 | Betacone Hip Prosthesis SystemLWJ · Traditional | Waldemar Link GmbH & Co. KG | 11/18/2005SE |
| K050262 | U2 Acetabular ComponentLWJ · Traditional | United Orthopedic Corp. | 08/15/2005SE |
| K042344 | Excia Total Hip SystemLWJ · Abbreviated | Aesculap, Inc. | 03/16/2005SE |
More from Aesculap, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K070061 | 36MM Cocr Femoral Head and 36MM Acetabular InsertLWJ · Special | 01/31/2007SE |
| K060635 | Consensus Acetabular Shell SystemLPH · Special | 04/28/2006SE |
| K030151 | Consensus Hip System, Unisyn Hip SystemLZO · Traditional | 04/10/2003SE |
| K030205 | Consensus Unipolar Head, CocrKWL · Traditional | 04/01/2003SE |
| K021466 | Consensus Acetabular Insert, Cross-Linked PolyethyleneLPH · Traditional | 07/24/2002SE |
| K020153 | Consensus Acetablar Shell, Ti CoatedLPH · Traditional | 04/15/2002SE |
| K003649 | Triton Hip SystemLWJ · Traditional | 02/23/2001SE |
| K001456 | Consensus Knee SystemJWH · Traditional | 08/07/2000SE |
| K983004 | Consensus Femoral Component, Porous, Cocr/TiJWH · Traditional | 11/25/1998SE |
| K964395 | Patient Specific Implant (Psi) Hip Femoral ComponentLZO · Traditional | 01/27/1997SE |
Questions and answers
When was Unisyn Ha Plasma Modular Hip cleared by the FDA?
Unisyn Ha Plasma Modular Hip (K062383) received a 510(k) decision of Substantially Equivalent on December 21, 2006, 128 days after the submission was received.
What is the product code of K062383?
The FDA product code is LWJ – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3360.