Data / Medical devices / United States / Acuitive Technologies
Acuitive Technologies: FDA-registered device maker in Allendale, NJ, United States, 5 510(k) clearances
Acuitive Technologies is registered with the FDA (registration 3014560508) in Allendale, NJ, United States. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated November 6, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014560508
- Address
- 50 Commerce Drive, Allendale, NJ, United States, 07401
- Owner or operator
- Acuitive Technologies (10079115)
- Roles
- Manufacturer
- First device listed
- November 19, 2020
- Registered through
- 2026
- Brand names listed
- CITRELOCK DUO, Citrefix Knotless Suture Anchor, Citregen Tendon Interference Screw and Citrelock, Citregraft, Citrespline and Citrelock ACL Implants
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fastener, Fixation, Biodegradable, Soft Tissue | MAI | 2 | Manufacturer | accessdata.fda.gov |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | 2 | Manufacturer | accessdata.fda.gov |
| Filler, Bone Void, Calcium Compound | MQV | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| November 6, 2024 | K240450 | Citrepore | MQV | Substantially Equivalent | Acuitive Technologies, Inc. | accessdata.fda.gov |
| September 20, 2023 | K232592 | CITRELOCK® DUO | MBI | Substantially Equivalent | Acuitive Technologies, Inc. | accessdata.fda.gov |
| February 24, 2021 | K210239 | CITRESPLINE and CITRELOCK ACL Implants | MAI | Substantially Equivalent | Acuitive Technologies, Inc. | accessdata.fda.gov |
| February 5, 2021 | K203334 | The Citrefix Knotless Suture Anchor | MAI | Substantially Equivalent | Acuitive Technologies, Inc. | accessdata.fda.gov |
| October 7, 2020 | K200725 | Citregen Tendon Interference Screw and Citrelock | MAI | Substantially Equivalent | Acuitive Technologies | accessdata.fda.gov |
Compare with other makers
- All makers of Filler, Bone Void, Calcium Compound
- All makers of Fastener, Fixation, Biodegradable, Soft Tissue
- All makers of Fastener, Fixation, Nondegradable, Soft Tissue
Updated November 6, 2024. 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.