Contract manufacturerKAPSTONE MANUFACTURING (Charlotte, NC)North CarolinaGastroenterology and urologyOrthopedicRadiologyClass IClass II
KAPSTONE MANUFACTURING
Contract manufacturer ยท Charlotte, NC
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3016248538 (openFDA record; or search FDA's registration database)
- FEI number
- 3016248538
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- Kapstone Manufacturing (FDA owner/operator no. 10062247)
- Registered address
- 520 Elliot St, Charlotte, NC 28202
- Contract listings
- 5 device listings, 6 product codes, first listed Dec 13, 2022
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| FHQ | Holder, Needle, Gastroenterologic | Class I | Gastroenterology and urology | Contract manufacturing | Jun 15, 2026 |
| HWT | Template | Class I | Orthopedic | Contract manufacturing | Dec 13, 2022 |
| JAK | System, X-Ray, Tomography, Computed | Class II | Radiology | Contract manufacturing | Sep 3, 2026 |
| JDR | Staple, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | May 22, 2025 |
| LXH | Orthopedic Manual Surgical Instrument | Class I | Orthopedic | Contract manufacturing | May 22, 2025 |
| OWB | Interventional Fluoroscopic X-Ray System | Class II | Radiology | Contract manufacturing | Sep 3, 2026 |