Data / Medical devices / United States / Happe Spine
Happe Spine: FDA-registered device maker in Grand Rapids, MI, United States, 1 510(k) clearance
Happe Spine is registered with the FDA (registration 3027726367) in Grand Rapids, MI, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 28, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027726367
- Address
- 2851 Charlevoix Dr. SE Suite 327, Grand Rapids, MI, United States, 49546
- Owner or operator
- HAPPE Spine (10088529)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- August 8, 2023
- Registered through
- 2026
- Brand names listed
- Cervical Mallet, Dual Ended Trial Handle, INTEGRATE, INTEGRATE-C, INTEGRATE-C Case, Inserter Handle, Inserter Threaded Rod, Rasp Handle and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Fixation, Spinal Intervertebral Body | LYQ | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | 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 |
|---|---|---|---|---|---|---|
| April 28, 2023 | K222004 | INTEGRATE -C Interbody Fusion System | ODP | Substantially Equivalent | Happe Spine | accessdata.fda.gov |
Compare with other makers
- All makers of Accessories, Fixation, Spinal Intervertebral Body
- All makers of Intervertebral Fusion Device With Bone Graft, Cervical
Updated April 28, 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.