Coonrad III Total Elbow
FDA 510(k) K883665 · Zimmer, Inc.
510(k) numberK883665
Submission
- Device name
- Coonrad III Total Elbow
- Applicant
- Zimmer, Inc.
Warsaw, IN, US - Received
- August 26, 1988
- Decision date
- February 3, 1989
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
Device classification
- Product code
- JDC – Prosthesis, Elbow, Constrained, Cemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3150
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code JDC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K181362 | TEMA Elbow SystemJDC · Traditional | Lima Corporate S.P.A. | 02/16/2019SE |
| K181307 | Zimmer Nexel Total Elbow, Connrad/Morrey Total ElbowJDC · Traditional | Zimmer, Inc. | 01/28/2019SE |
| K153398 | Comprehensive SRS/Nexel ElbowJDC · Traditional | Biomet Manufacturing Corp | 02/03/2016SE |
| K150501 | Zimmer Nexel Total Elbow Ulnar Cement DiverterJDC · Traditional | Zimmer, Inc. | 04/23/2015SE |
| K123862 | Zimmer Nexel Total ElbowJDC · Traditional | Zimmer, Inc. | 03/12/2013SE |
| K090473 | Discovery Elbow - X-SmallJDC · Special | Biomet Manufacturing Corp | 03/25/2009SE |
| K060696 | Acclaim Total Elbow SystemJDC · Special | DePuy Orthopaedics, Inc. | 04/14/2006SE |
| K053189 | Coonrad/Morrey Total Elbow, Model 8105 SeriesJDC · Special | Zimmer, Inc. | 12/09/2005SE |
| K051975 | Porous Coated Discovery ElbowJDC · Special | Biomet, Inc. | 09/06/2005SE |
| K042664 | LPS Upper ExtremityJDC · Traditional | Depuy, Inc. | 12/08/2004SE |
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Questions and answers
When was Coonrad III Total Elbow cleared by the FDA?
Coonrad III Total Elbow (K883665) received a 510(k) decision of Substantially Equivalent for Some Indications on February 3, 1989, 161 days after the submission was received.
What is the product code of K883665?
The FDA product code is JDC – Prosthesis, Elbow, Constrained, Cemented, a Class II (moderate risk) device regulated under 21 CFR 888.3150.