Macropore Os Trauma
FDA 510(k) K021164 · Macropore Biosurgery, Inc.
510(k) numberK021164
Submission
- Device name
- Macropore Os Trauma
- Applicant
- Macropore Biosurgery, Inc.
San Diego, CA, US - Received
- April 11, 2002
- Decision date
- July 1, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HRS – Plate, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261647 | Tempo Plating System; Ultra Compression Screw SystemHRS · Traditional | Pace Surgical | 09/03/2026SE |
| K261830 | FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…HRS · Traditional | Ortler Global Tibbi Gerecler Anonim Sirketi | 08/28/2026SE |
| K262537 | Versalock Sterile Plating SystemHRS · Special | GM Dos Reis Industria e Comercio Ltda. | 08/19/2026SE |
| K260277 | Mikron Trauma Bone Plate& Screw SystemHRS · Traditional | Mikron Makina San. ve Tic. Ltd. Sti. | 08/13/2026SE |
| K261511 | Xpert AnkleHRS · Traditional | Newclip Technics | 07/28/2026SE |
| K261406 | Versalock Proximal Tibial Plating SystemHRS · Traditional | GM Dos Reis Industria e Comercio Ltda. | 07/21/2026SE |
| K262032 | TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…HRS · Special | TriMed, Inc. | 07/16/2026SE |
| K261191 | Alians Elbow SHRS · Traditional | Newclip Technics | 07/08/2026SE |
| K261054 | RibPlate SystemHRS · Traditional | Stryker Leibinger GmbH & Co KG | 07/01/2026SE |
| K261351 | SALGINA 2.5mm Distal Radius SystemHRS · Traditional | Bonebridge AG | 06/26/2026SE |
More from Bonebridge AG
| 510(k) | Device | Decision |
|---|---|---|
| K042261 | Macropore Puricel Lipoplasty SystemQPB · Traditional | 09/20/2004SE |
| K041105 | Macropore Hydrosorb Spine SystemKWQ · Traditional | 07/28/2004SE |
| 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 |
| 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 Os Trauma cleared by the FDA?
Macropore Os Trauma (K021164) received a 510(k) decision of Substantially Equivalent on July 1, 2002, 81 days after the submission was received.
What is the product code of K021164?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.