Comprehensive SRS/Nexel Elbow
FDA 510(k) K153398 · Biomet Manufacturing Corp
510(k) numberK153398
Submission
- Device name
- Comprehensive SRS/Nexel Elbow
- Applicant
- Biomet Manufacturing Corp
Warsaw, IN, US - Received
- November 24, 2015
- Decision date
- February 3, 2016
- 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 |
| 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 |
| K040389 | Coonrad/Morrey Elbow Cement RestrictorJDC · Traditional | Zimmer, Inc. | 05/17/2004SE |
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| K211729 | Comprehensive® Convertible Glenoid - Vivacit-E LinerPHX · Traditional | 11/04/2021SE |
| K202232 | Comprehensive Vault Reconstruction SystemPHX · Traditional | 02/19/2021SE |
| K193038 | Comprehensive Shoulder SystemMBF · Traditional | 10/28/2020SE |
| K182516 | Comprehensive Nano Stemless ShoulderPKC · Traditional | 04/22/2019SE |
| K181611 | Comprehensive Reverse Shoulder SystemPHX · Traditional | 09/24/2018SE |
| K173411 | Comprehensive Segmental Revision System (SRS)PHX · Traditional | 02/08/2018SE |
| K172502 | Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate…PHX · Traditional | 01/03/2018SE |
| K163651 | ExpressBraid Graft ManipulationGAT · Traditional | 02/17/2017SE |
Questions and answers
When was Comprehensive SRS/Nexel Elbow cleared by the FDA?
Comprehensive SRS/Nexel Elbow (K153398) received a 510(k) decision of Substantially Equivalent on February 3, 2016, 71 days after the submission was received.
What is the product code of K153398?
The FDA product code is JDC – Prosthesis, Elbow, Constrained, Cemented, a Class II (moderate risk) device regulated under 21 CFR 888.3150.