Inter-Op Durasul Acetabular Inserts (4MM)
FDA 510(k) K002575 · Sulzer Orthopedics, Inc.
510(k) numberK002575
Submission
- Device name
- Inter-Op Durasul Acetabular Inserts (4MM)
- Applicant
- Sulzer Orthopedics, Inc.
Austin, TX, US - Received
- August 18, 2000
- Decision date
- November 15, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
| 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 |
|---|---|---|
| K022985 | Ascendent Acetabular SystemLZO · Traditional | 12/05/2002SE |
| K021578 | Natural-Knee II System Cocr Tibial BaseplateJWH · Traditional | 08/09/2002SE |
| K020713 | MS-30 Lateral Femoral StemLZO · Traditional | 05/14/2002SE |
| K013935 | Allofit Acetabular System 32MM Alpha Durasul InsertsLZO · Special | 12/13/2001SE |
| K013031 | Most Options SystemKRO · Traditional | 12/07/2001SE |
| K012739 | Converge Acetabular SystemLPH · Traditional | 11/14/2001SE |
| K012961 | Sulzer Orthopedics Converge Acetabular SystemJDI · Special | 10/18/2001SE |
| K011954 | Sulzer Orthopedics Allegretto Unicompartmental KneeHSX · Traditional | 09/19/2001SE |
| K010839 | CLS Varus Stem/Cls 135 StemLZO · Special | 04/18/2001SE |
| K003758 | Allofit Acetabular SystemKWA · Traditional | 03/07/2001SE |
Questions and answers
When was Inter-Op Durasul Acetabular Inserts (4MM) cleared by the FDA?
Inter-Op Durasul Acetabular Inserts (4MM) (K002575) received a 510(k) decision of Substantially Equivalent on November 15, 2000, 89 days after the submission was received.
What is the product code of K002575?
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.