100KGY E-Poly Acetabular Liners- Additional Profiles: +3 Maxrom and +3 Hi-Wall
FDA 510(k) K090103 · Biomet, Inc.
510(k) numberK090103
Submission
- Device name
- 100KGY E-Poly Acetabular Liners- Additional Profiles: +3 Maxrom and +3 Hi-Wall
- Applicant
- Biomet, Inc.
Warsaw, IN, US - Received
- January 15, 2009
- Decision date
- February 11, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| K051844 | Equator Plus Acetabular Cup SystemMAY · Traditional | Portland Orthopaedics Pty. , Ltd. | 10/07/2005SE |
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Questions and answers
When was 100KGY E-Poly Acetabular Liners- Additional Profiles: +3 Maxrom and +3 Hi-Wall cleared by the FDA?
100KGY E-Poly Acetabular Liners- Additional Profiles: +3 Maxrom and +3 Hi-Wall (K090103) received a 510(k) decision of Substantially Equivalent on February 11, 2009, 27 days after the submission was received.
What is the product code of K090103?
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.