Coonrad/Morrey Total Elbow, New Hinge Pin
FDA 510(k) K973357 · Zimmer, Inc.
510(k) numberK973357
Submission
- Device name
- Coonrad/Morrey Total Elbow, New Hinge Pin
- Applicant
- Zimmer, Inc.
Warsaw, IN, US - Received
- September 8, 1997
- Decision date
- March 2, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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/Morrey Total Elbow, New Hinge Pin cleared by the FDA?
Coonrad/Morrey Total Elbow, New Hinge Pin (K973357) received a 510(k) decision of Substantially Equivalent on March 2, 1998, 175 days after the submission was received.
What is the product code of K973357?
The FDA product code is JDC – Prosthesis, Elbow, Constrained, Cemented, a Class II (moderate risk) device regulated under 21 CFR 888.3150.