F-24 Femoral Hip Prosthesis
FDA 510(k) K901687 · Med-Tek Corp.
510(k) numberK901687
Submission
- Device name
- F-24 Femoral Hip Prosthesis
- Applicant
- Med-Tek Corp.
Indianapolis, IN, US - Received
- April 12, 1990
- Decision date
- September 7, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K062383 | Unisyn Ha Plasma Modular HipLWJ · Special | Hayes Medical, Inc. | 12/21/2006SE |
| 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 |
More from United Orthopedic Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K903234 | F-19 Total Hip ProsthesisJDI · Traditional | 10/10/1990SE |
| K901451 | F-20 Cemented Metal-Backed Acetabular CupJDI · Traditional | 08/31/1990SN |
| K900428 | Anesthesia Breathing CircuitsCAI · Traditional | 08/17/1990SE |
| K901626 | H.N. Metal Backed Acetabular Cup, NoncementedKWA · Traditional | 08/14/1990SE |
| K901594 | H.N. Total Hip ProsthesisLWJ · Traditional | 08/03/1990SE |
| K901480 | F-20 Total Hip ProsthesisJDI · Traditional | 06/12/1990SE |
| K901273 | L.M.S. Self-Detachable Broach with StopHTY · Traditional | 06/05/1990SE |
| K901272 | Orion Blade Plate for Tibial OsteotomyKTT · Traditional | 04/23/1990SE |
| K901240 | Astel Non-Metal Backed Acetabular Cup for CementedJDI · Traditional | 03/26/1990SE |
| K894978 | Bacterial FilterCAH · Traditional | 11/02/1989SE |
Questions and answers
When was F-24 Femoral Hip Prosthesis cleared by the FDA?
F-24 Femoral Hip Prosthesis (K901687) received a 510(k) decision of Substantially Equivalent on September 7, 1990, 148 days after the submission was received.
What is the product code of K901687?
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.