Kirschner C-2 Osteocap Total Hip System
FDA 510(k) K935951 · Kirschner Medical Corp.
510(k) numberK935951
Submission
- Device name
- Kirschner C-2 Osteocap Total Hip System
- Applicant
- Kirschner Medical Corp.
Fair Lawn, NJ, US - Received
- December 13, 1993
- Decision date
- July 18, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JDI – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3350
- Specialty
- Orthopedic
- Implant
- Yes
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| K241716 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge…JDI · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 08/02/2024SE |
| K240418 | Stryker Orthopaedics Hip Systems Labeling UpdateJDI · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 04/12/2024SE |
| K233261 | Global Modular Replacement SystemJDI · Traditional | Howmedica Osteonics Corp. A.K.A. Stryker… | 12/08/2023SE |
| K222056 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge KneeJDI · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 01/26/2023SE |
| K220216 | C-Stem AMT LE ProsthesisJDI · Traditional | Depuy Ireland UC | 07/22/2022SE |
More from Depuy Ireland UC
| 510(k) | Device | Decision |
|---|---|---|
| K940537 | Kirschner(R) Modular Ii-C(Tm) Total Shoulder SystemKWT · Traditional | 08/29/1995SE |
| K936274 | Kirschner Performance Posterior Stabilized Total Knee SystemJWH · Traditional | 01/18/1995SE |
| K942891 | Summit Total Hip SystemMEH · Traditional | 11/02/1994SE |
| K941486 | Integrity Total Hip System, Non-PorousJDI · Traditional | 09/20/1994SE |
| K933843 | Line Extension for Kirschner Performance Total Knee System, Porous CoatedJWH · Traditional | 08/05/1994SE |
| K935206 | Kirschner Integrity Acetabular Cup ModificationJDI · Traditional | 07/13/1994SE |
| K934589 | Kirschner Performance Total Knee System Porous CoatedJWH · Traditional | 07/13/1994SN |
| K934694 | Kirschner Zirconia Femoral HeadLZO · Traditional | 05/18/1994SE |
| K920188 | Threaded PinsMBJ · Traditional | 05/12/1993SE |
| K921837 | Medicam 900 Insufflator with AccessoriesHIF · Traditional | 02/05/1993SE |
Questions and answers
When was Kirschner C-2 Osteocap Total Hip System cleared by the FDA?
Kirschner C-2 Osteocap Total Hip System (K935951) received a 510(k) decision of Substantially Equivalent on July 18, 1994, 217 days after the submission was received.
What is the product code of K935951?
The FDA product code is JDI – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, a Class II (moderate risk) device regulated under 21 CFR 888.3350.