Modula Options for Severe Bone Loss and Trauma
FDA 510(k) K964350 · Intermedics Orthopedics
510(k) numberK964350
Submission
- Device name
- Modula Options for Severe Bone Loss and Trauma
- Applicant
- Intermedics Orthopedics
Austin, TX, US - Received
- October 31, 1996
- Decision date
- January 16, 1997
- 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 |
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| 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 |
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More from Depuy Ireland UC
| 510(k) | Device | Decision |
|---|---|---|
| K970300 | Natural-Hip System Porous Stem with Ha/CstiLPH · Traditional | 07/03/1997SE |
| K970498 | Natural-Knee II Revision Femoral Spacer LugsJWH · Traditional | 04/30/1997SE |
| K970166 | Natural-Hip System Cocr Revision StemLZO · Traditional | 04/08/1997SE |
| K970567 | Select Shoulder Curved-Back Pegged All Poly GlenoidsKWT · Traditional | 02/27/1997SE |
| K964357 | Natural-Hip System Cocr StemLZO · Traditional | 01/27/1997SE |
| K962190 | Patellofemoral Joint ProsthesisKRR · Traditional | 10/28/1996SE |
| K963266 | Natural Hip System Porous Stem - Collarless, CollaredLPH · Traditional | 10/15/1996SE |
| K963155 | Intermoore Fracture Hip Stem (Modify)LWJ · Traditional | 10/01/1996SE |
| K962315 | Select Shoulder Cocr Humeral Stem ComponentKWT · Traditional | 09/03/1996SE |
| K962289 | Select Shoulder Cocr Humeral Stem ComponentHSD · Traditional | 08/29/1996SE |
Questions and answers
When was Modula Options for Severe Bone Loss and Trauma cleared by the FDA?
Modula Options for Severe Bone Loss and Trauma (K964350) received a 510(k) decision of Substantially Equivalent on January 16, 1997, 77 days after the submission was received.
What is the product code of K964350?
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.