Macropore Ib Resorbable Plug
FDA 510(k) K011715 · Macropore Biosurgery, Inc.
510(k) numberK011715
Submission
- Device name
- Macropore Ib Resorbable Plug
- Applicant
- Macropore Biosurgery, Inc.
San Diego, CA, US - Received
- June 4, 2001
- Decision date
- August 27, 2001
- Decision
- Unknown (SESU)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JDI – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3350
- Specialty
- Orthopedic
- Implant
- Yes
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| K031785 | Macropore Cardio-Wrap (TS)OMH · Traditional | 09/04/2003SE |
| K024169 | Macropore Os ReconstructionEZX · Traditional | 07/01/2003SE |
| K023643 | Macropore Surgical Barrier FilmMTZ · Traditional | 02/21/2003SE |
| K021164 | Macropore Os TraumaHRS · Traditional | 07/01/2002SE |
| K012025 | Macropore Surgiwrap (TS)FTL · Traditional | 12/03/2001SE |
| K012769 | Macropore ENT Reconstruction FilmNHB · Traditional | 10/25/2001SE |
| K012413 | Macropore FX, PS, NS, LPJEY · Traditional | 09/18/2001SE |
Questions and answers
When was Macropore Ib Resorbable Plug cleared by the FDA?
Macropore Ib Resorbable Plug (K011715) received a 510(k) decision of Unknown on August 27, 2001, 84 days after the submission was received.
What is the product code of K011715?
The FDA product code is JDI – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, a Class II (moderate risk) device regulated under 21 CFR 888.3350.