Equator Plus Acetabular Cup System
FDA 510(k) K051844 · Portland Orthopaedics Pty. , Ltd.
510(k) numberK051844
Submission
- Device name
- Equator Plus Acetabular Cup System
- Applicant
- Portland Orthopaedics Pty. , Ltd.
Stillwater, MN, US - Received
- July 7, 2005
- Decision date
- October 7, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MAY – Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3353
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code MAY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K123604 | Abg III Monolithic Hip StemMAY · Traditional | Howmedica Osteonics Corp. | 08/16/2013SE |
| K110807 | Abg II Monolithic Hip StemMAY · Traditional | Stryker Corp. | 05/25/2011SE |
| K090103 | 100KGY E-Poly Acetabular Liners- Additional Profiles: +3 Maxrom and +3 Hi-WallMAY · Special | Biomet, Inc. | 02/11/2009SE |
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| 510(k) | Device | Decision |
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| K063278 | Portland Cobalt Chrome Femoral HeadJDI · Traditional | 01/12/2007SE |
| K061564 | Portland Ceramic (Biolox-Forte) Femoral HeadLZO · Traditional | 09/01/2006SE |
| K053417 | M-Cor Hip Replacement SystemLPH · Traditional | 07/20/2006SE |
| K032641 | Modification to: the Margron Hip Replacement SystemMEH · Special | 01/20/2004SE |
| K992815 | The Margron Hip Replacement SystemMEH · Traditional | 02/07/2000SE |
Questions and answers
When was Equator Plus Acetabular Cup System cleared by the FDA?
Equator Plus Acetabular Cup System (K051844) received a 510(k) decision of Substantially Equivalent on October 7, 2005, 92 days after the submission was received.
What is the product code of K051844?
The FDA product code is MAY – Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish, a Class II (moderate risk) device regulated under 21 CFR 888.3353.