Porocoat Mark IV Elbow
FDA 510(k) K823473 · Depuy, Inc.
510(k) numberK823473
Submission
- Device name
- Porocoat Mark IV Elbow
- Applicant
- Depuy, Inc.
Mchenry, IL, US - Received
- November 22, 1982
- Decision date
- January 20, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JDB – Prosthesis, Elbow, Semi-Constrained, Cemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3160
- Specialty
- Orthopedic
- Implant
- Yes
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| K222807 | TEMA Elbow system - Line extensionJDB · Traditional | Lima Corporate S.P.A. | 10/26/2022SE |
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| K171010 | Latitude EV Total Elbow ArthroplastyJDB · Traditional | Tornier, Inc. | 08/31/2017SE |
| K102180 | Rhead Radial Head Extended StemsJDB · Traditional | Small Bone Innovations, Inc. | 12/20/2010SE |
| K100562 | Latitude Elbow ProsthesisJDB · Special | Tornier, Inc. | 06/29/2010SE |
| K070787 | Latitude Elbow ProthesisJDB · Special | Tornier | 08/24/2007SE |
| K070236 | Sbi Lateral Radio CapitellumJDB · Special | Small Bone Innovations, Inc. | 02/21/2007SE |
| K060438 | RHSJDB · Traditional | Tornier | 04/18/2006SE |
| K060038 | Sbi Radio-Capitellar ImplantJDB · Traditional | Small Bone Innovations, Inc. | 03/30/2006SE |
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| K033329 | Depuy Ace Universal and Troch Entry Femoral Nail SystemsHSB · Traditional | 11/14/2003SE |
| K032151 | Depuy Sigma Tibial Inserts and Co-Cr Tibial TraysJWH · Special | 09/26/2003SE |
| K020541 | Agility Ankle Revision ProsthesisHSN · Traditional | 05/20/2002SE |
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Questions and answers
When was Porocoat Mark IV Elbow cleared by the FDA?
Porocoat Mark IV Elbow (K823473) received a 510(k) decision of Substantially Equivalent on January 20, 1983, 59 days after the submission was received.
What is the product code of K823473?
The FDA product code is JDB – Prosthesis, Elbow, Semi-Constrained, Cemented, a Class II (moderate risk) device regulated under 21 CFR 888.3160.