Data / Medical devices / United States / Genesis Biologics, Inc.
Genesis Biologics, Inc.: FDA-registered device maker in Irvine, CA, United States, 3 510(k) clearances
Genesis Biologics, Inc. is registered with the FDA (registration 3016948539) in Irvine, CA, United States. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated June 9, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016948539
- FEI number
- 3008066433
- Address
- 17791 Mitchell North Suite D, Irvine, CA, United States, 92614
- Owner or operator
- Genesis Biologics, Inc. (10074842)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- July 11, 2022
- Registered through
- 2026
- Brand names listed
- Adaptive Autologous Processing System, AlternatiV+ Max Knotless Anchor, AlternatiV+ Screw-In Anchor, Awl, Awl/Tapper, Drill Bit, Drill Guide, Dual Pitch AWL/Tapper and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fastener, Fixation, Biodegradable, Soft Tissue | MAI | 2 | Complaint file establishment | accessdata.fda.gov |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | 2 | Complaint file establishment | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Complaint file establishment | accessdata.fda.gov |
| Platelet And Plasma Separator For Bone Graft Handling | ORG | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 9, 2023 | K230892 | Fixone Biocomposite Anchor | MAI | Substantially Equivalent | Aju Pharm Co., Ltd. | accessdata.fda.gov |
| March 23, 2023 | K222423 | Fixone All Suture Anchor | MBI | Substantially Equivalent | Aju Pharm Co., Ltd. | accessdata.fda.gov |
| December 25, 2021 | K203523 | Fixone hybrid knotless anchor | MAI | Substantially Equivalent | Aju Pharm Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Fastener, Fixation, Nondegradable, Soft Tissue
- All makers of Orthopedic Manual Surgical Instrument
- All makers of Fastener, Fixation, Biodegradable, Soft Tissue
- All makers of Platelet And Plasma Separator For Bone Graft Handling
Updated June 9, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.