Data / Medical devices / United States / Enhatch, Inc
Enhatch, Inc: FDA-registered device maker in Hasbrouck Heights, NJ, United States, 1 510(k) clearance
Enhatch, Inc is registered with the FDA (registration 3030409224) in Hasbrouck Heights, NJ, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 20, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030409224
- Address
- 411 State Rt 17 Ste 500, Hasbrouck Heights, NJ, United States, 07604
- Owner or operator
- Enhatch, Inc (10089831)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- January 11, 2024
- Registered through
- 2026
- Brand names listed
- Intelligent Surgery Knee, United Orthopedic Knee Patient Specific Instrumentation
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Knee Arthroplasty Implantation System | OOG | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Orthopaedic Surgical Planning And Instrument Guides | PBF | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 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 |
|---|---|---|---|---|---|---|
| December 20, 2023 | K230850 | United Orthopedic Knee Patient Specific Instrumentation | OOG | Substantially Equivalent | Enhatch, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Knee Arthroplasty Implantation System
- All makers of Orthopaedic Surgical Planning And Instrument Guides
- All makers of System, Image Processing, Radiological
Updated December 20, 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.