Nexlock Femoral Stem
FDA 510(k) K955171 · Nexmed, Inc.
510(k) numberK955171
Submission
- Device name
- Nexlock Femoral Stem
- Applicant
- Nexmed, Inc.
Palm Desert, CA, US - Received
- November 13, 1995
- Decision date
- February 9, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JDG – Prosthesis, Hip, Femoral Component, Cemented, Metal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3360
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code JDG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K212431 | Biomet Answer/Impact/Integral Distal Centralizer/Centering SleeveJDG · Traditional | Biomet, Inc. | 02/07/2022SE |
| K193546 | Distal CentralizersJDG · Traditional | Biomet, Inc. | 09/25/2020SE |
| K173499 | Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsJDG · Traditional | Stryker Orthopaedics | 03/19/2018SE |
| K001984 | Progeny Forged Cocr Cemented Femoral ComponentJDG · Traditional | Stelkast Company | 09/27/2000SE |
| K992234 | The Taper-Fit Total Hip SystemJDG · Traditional | Corin USA | 11/10/1999SE |
| K962002 | Aura Hip System Calcar Replacement Femoral StemJDG · Traditional | Exactech, Inc. | 08/08/1996SE |
| K953653 | Lubinus SP II Hip SystemJDG · Traditional | Turnkey Intergration USA, Inc. | 11/06/1995SE |
| K953067 | Hip Fracture Stem Fenestration PlugJDG · Traditional | Howmedica Corp. | 08/21/1995SE |
| K945783 | Orthomet Titanium Hybrid Femoral StemJDG · Traditional | Orthomet, Inc. | 05/30/1995SE |
| K951083 | Proform Cemented Femoral ComponentJDG · Traditional | Stelkast Company | 05/22/1995SN |
More from Stelkast Company
| 510(k) | Device | Decision |
|---|---|---|
| K033580 | Nexflex Total Hip SystemLPH · Special | 08/05/2004SE |
| K991882 | Nexflex Total Knee SystemJWH · Traditional | 12/08/1999SE |
| K955170 | Nexflex Femoral Stem, Standard DesignLPH · Traditional | 02/09/1996SE |
| K952629 | Nexflex Total Hip SystemJDI · Traditional | 09/08/1995SE |
| K951656 | Nexmed Cancellous Bone ScrewsHWC · Traditional | 07/18/1995SN |
Questions and answers
When was Nexlock Femoral Stem cleared by the FDA?
Nexlock Femoral Stem (K955171) received a 510(k) decision of Substantially Equivalent on February 9, 1996, 88 days after the submission was received.
What is the product code of K955171?
The FDA product code is JDG – Prosthesis, Hip, Femoral Component, Cemented, Metal, a Class II (moderate risk) device regulated under 21 CFR 888.3360.