Zweymuller Cup
FDA 510(k) K851213 · Allo Pro Corp.
510(k) numberK851213
Submission
- Device name
- Zweymuller Cup
- Applicant
- Allo Pro Corp.
Clearwater, FL, US - Received
- March 26, 1985
- Decision date
- May 28, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KWA – Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
- Device class
- Class III (high risk)
- Regulation
- 21 CFR 888.3330
- Specialty
- Orthopedic
- Implant
- Yes
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| K122778 | Profemur Z Revision Hip StemKWA · Special | Wrightmedicaltechnologyinc | 10/11/2012SE |
| K121544 | Dynasty Biofoam ShellKWA · Traditional | Wrightmedicaltechnologyinc | 07/30/2012SE |
| K113271 | Metal-On-Metal Hip Systems-Additional ContraindicationsKWA · Traditional | Biomet Manufacturing, Inc. | 05/18/2012SE |
| K113322 | Conserve Thin ShellKWA · Special | Wrightmedicaltechnologyinc | 02/03/2012SE |
| K112080 | Preserve Hip StemKWA · Special | Wrightmedicaltechnologyinc | 12/28/2011SE |
| K112150 | Profemur Gladiator Ha Hip StemKWA · Traditional | Wrightmedicaltechnologyinc | 11/23/2011SE |
| K113019 | Profemur XM Wingless Distal Centralizer, Perfecta Distal CentralizerKWA · Special | Wrightmedicaltechnologyinc | 11/10/2011SE |
| K111910 | Gladiator Hip StemKWA · Traditional | Wrightmedicaltechnologyinc | 10/14/2011SE |
| K110836 | CLS Brevius Stem with Kinectiv TechnologyKWA · Traditional | Zimmer GmbH | 10/07/2011SE |
| K110400 | Taperloc Complete Microplasty StemKWA · Traditional | Biomet Manufacturing Corp | 09/30/2011SE |
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| K901581 | GSB ElbowJDC · Traditional | 10/22/1990SE |
| K900425 | Surgical Cotton GlovesLYU · Traditional | 09/07/1990SE |
| K900392 | Centering PlugLZN · Traditional | 03/01/1990SE |
| K896669 | Weber PermalockLZO · Traditional | 02/06/1990SN |
| K892644 | Biolox Ceramic BallLZO · Traditional | 10/19/1989SE |
| K885049 | Rs-Cup Acetabular ProsthesisKWA · Traditional | 01/13/1989SE |
| K864999 | Kennedy StemJDI · Traditional | 09/09/1987SE |
| K871453 | Zweymueller-Sl Hip Prosthesis StemKWA · Traditional | 07/13/1987SE |
| K841391 | Weber-Stuhmer Hip Prosthesis StemJDI · Traditional | 04/13/1984SE |
| K830948 | Weber/Stiihmer Femoral Head ProsthesisJDI · Traditional | 07/12/1983SE |
Questions and answers
When was Zweymuller Cup cleared by the FDA?
Zweymuller Cup (K851213) received a 510(k) decision of Substantially Equivalent on May 28, 1985, 63 days after the submission was received.
What is the product code of K851213?
The FDA product code is KWA – Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component), a Class III (high risk) device regulated under 21 CFR 888.3330.