Consensus Posterior Stabilized Knee-Intercondylar Notch Router
FDA 510(k) K962215 · U.S. Medical Products, Inc.
510(k) numberK962215
Submission
- Device name
- Consensus Posterior Stabilized Knee-Intercondylar Notch Router
- Applicant
- U.S. Medical Products, Inc.
Austin, TX, US - Received
- June 10, 1996
- Decision date
- August 15, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HWE – Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4820
- Specialty
- General, Plastic Surgery
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More from Aesculap, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K954818 | Consensus Posterior Stabilized KneeJWH · Traditional | 05/22/1996SN |
| K953443 | Consensus PCL Subsituting Tibial InsertJWH · Traditional | 04/26/1996SE |
| K960302 | Consensus Acetabular Shell, All UhmwpeJDI · Traditional | 04/01/1996SE |
| K952943 | Consensus All Poly TibiaJWH · Traditional | 04/01/1996SE |
| K960340 | Consensus Apex Dome Hole PlugJDI · Traditional | 03/15/1996SE |
| K960339 | Consensus 22MM Cocrmo Femoral HeadJDI · Traditional | 02/21/1996SE |
| K960156 | Consensus 32MM Cocrmo Femoral HeadJDI · Traditional | 02/21/1996SE |
| K960151 | Consensus 26MM Cocrmo Femoral HeadJDI · Traditional | 02/21/1996SE |
| K955386 | Consensus Zirconia Femoral HeadLZO · Traditional | 02/20/1996SN |
| K953792 | Consensus Zirconia Head Size -3.5, 0, +5LZO · Traditional | 11/06/1995SN |
Questions and answers
When was Consensus Posterior Stabilized Knee-Intercondylar Notch Router cleared by the FDA?
Consensus Posterior Stabilized Knee-Intercondylar Notch Router (K962215) received a 510(k) decision of Substantially Equivalent on August 15, 1996, 66 days after the submission was received.
What is the product code of K962215?
The FDA product code is HWE – Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment, a Class I (low risk) device regulated under 21 CFR 878.4820.