Biopro Polar Head
FDA 510(k) K100761 · Biopro, Inc.
510(k) numberK100761
Submission
- Device name
- Biopro Polar Head
- Applicant
- Biopro, Inc.
Port Huron, MI, US - Received
- March 17, 2010
- Decision date
- December 3, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWY – Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3390
- Specialty
- Orthopedic
- Implant
- Yes
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| K191297 | iNSitu Bipolar Hip SystemKWY · Traditional | Theken Companies, LLC | 09/17/2019SE |
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| 510(k) | Device | Decision |
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| K163627 | Shotel Ankle Arthrodesis Nail SystemHSB · Traditional | 09/14/2017SE |
| K162674 | BioPro Foot Plating SystemsHRS · Traditional | 06/16/2017SE |
| K132510 | Biopro - Infinity Plate Anchor SystemHTN · Traditional | 10/24/2013SE |
| K130298 | Biopro Kwick-Wire Universal Screw SystemJDW · Traditional | 06/18/2013SE |
| K121973 | Biopro Hemi-Edge Toe SystemKWD · Traditional | 10/30/2012SE |
| K101030 | Modification to HBS Headless Bone ScrewHWC · Special | 06/03/2010SE |
| K090208 | Biopro Femoral HeadsJDI · Traditional | 05/22/2009SE |
| K083490 | Biopro K-Wire, Models 16863, 17231, 17232, 18577, 18682-18685HTY · Traditional | 03/18/2009SE |
| K082705 | Biopro Bipolar Head, Models 18130-18152KWY · Traditional | 12/15/2008SE |
| K081149 | Biopro Go-Ez ScrewHWC · Traditional | 08/05/2008SE |
Questions and answers
When was Biopro Polar Head cleared by the FDA?
Biopro Polar Head (K100761) received a 510(k) decision of Substantially Equivalent on December 3, 2010, 261 days after the submission was received.
What is the product code of K100761?
The FDA product code is KWY – Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3390.