Hyalex Orthopaedics, Inc.
United Statesfrom the FDA registration address FDA FEI 3027313769
- Devices
- 15
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Hyalex Orthopaedics, Inc. makes
Hyalex Orthopaedics, Inc. manufactures the HYALEX® MTP Hemiarthroplasty Implant, a device designed for partial joint replacement in the metatarsophalangeal (MTP) joint, commonly used to treat conditions such as osteoarthritis or joint damage.
The company’s portfolio is regulated under FDA Class II devices and is listed via the 510(k) premarket notification process. The manufacturer is based in the United States.
Catalogue
Search and filter all 15 devicesCompany details
- FDA FEI number
- 3027313769
- DUNS number
- 080784794
- Address
- 99 Hayden Ave Bldg D Ste 340, Lexington, MA, 02421
- [email protected]
- Phone
- 781-778-3230
Frequently asked questions
How many devices does Hyalex Orthopaedics, Inc. have in the registry?
The registry currently lists 15 devices for Hyalex Orthopaedics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hyalex Orthopaedics, Inc.'s devices?
Among its 15 most recently registered devices, Hyalex Orthopaedics, Inc. has devices listed in FDA 510(k) (1 device) and FDA GUDID (14 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Hyalex Orthopaedics, Inc.'s devices fall under?
Among its 15 most recently registered devices, the classes recorded for Hyalex Orthopaedics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Hyalex Orthopaedics, Inc. in the registry?
The most recently registered devices listed for Hyalex Orthopaedics, Inc. include HYALEX Slalom™ MTP Hemiarthroplasty System PN-00720-10, HYALEX Slalom™ MTP Hemiarthroplasty System PN-00720-12, HYALEX Slalom™ MTP Hemiarthroplasty System PN-00734-12 and HYALEX Slalom™ MTP Hemiarthroplasty System PN-00734-10.