Macropore Hydrosorb Spine System
FDA 510(k) K041105 · Macropore Biosurgery, Inc.
510(k) numberK041105
Submission
- Device name
- Macropore Hydrosorb Spine System
- Applicant
- Macropore Biosurgery, Inc.
San Diego, CA, US - Received
- April 30, 2004
- Decision date
- July 28, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWQ – Appliance, Fixation, Spinal Intervertebral Body
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3060
- Specialty
- Orthopedic
- Implant
- Yes
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| K251940 | PathLoc Lumbar Plate SystemKWQ · Traditional | L&K BIOMED Co., Ltd. | 03/03/2026SE |
| K254182 | AsterKWQ · Traditional | Osteonic Co., Ltd. | 02/26/2026SE |
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| K252611 | aprevo® cervical plating systemKWQ · Traditional | Carlsmed, Inc. | 12/22/2025SE |
More from Carlsmed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K042261 | Macropore Puricel Lipoplasty SystemQPB · Traditional | 09/20/2004SE |
| K031955 | Macropore Surgi-Wrap Mast Bioresorbable SheetFTL · Traditional | 09/22/2003SE |
| 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 |
| K011715 | Macropore Ib Resorbable PlugJDI · Traditional | 08/27/2001SESU |
Questions and answers
When was Macropore Hydrosorb Spine System cleared by the FDA?
Macropore Hydrosorb Spine System (K041105) received a 510(k) decision of Substantially Equivalent on July 28, 2004, 89 days after the submission was received.
What is the product code of K041105?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.