Consensus Unipolar Head, Cocr
FDA 510(k) K030205 · Hayes Medical, Inc.
510(k) numberK030205
Submission
- Device name
- Consensus Unipolar Head, Cocr
- Applicant
- Hayes Medical, Inc.
El Dorado Hills, CA, US - Received
- January 21, 2003
- Decision date
- April 1, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KWL – Prosthesis, Hip, Hemi-, Femoral, Metal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3360
- Specialty
- Orthopedic
- Implant
- Yes
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More from Osteoremedies, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K070061 | 36MM Cocr Femoral Head and 36MM Acetabular InsertLWJ · Special | 01/31/2007SE |
| K062383 | Unisyn Ha Plasma Modular HipLWJ · Special | 12/21/2006SE |
| K060635 | Consensus Acetabular Shell SystemLPH · Special | 04/28/2006SE |
| K030151 | Consensus Hip System, Unisyn Hip SystemLZO · Traditional | 04/10/2003SE |
| 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 Consensus Unipolar Head, Cocr cleared by the FDA?
Consensus Unipolar Head, Cocr (K030205) received a 510(k) decision of Substantially Equivalent on April 1, 2003, 70 days after the submission was received.
What is the product code of K030205?
The FDA product code is KWL – Prosthesis, Hip, Hemi-, Femoral, Metal, a Class II (moderate risk) device regulated under 21 CFR 888.3360.