510(k) K253216
- Device
- IntraOp Alignment System; CONTOUR3D Bending System
- Applicant
- Alphatec Spine, Inc.
- 510(k) number
- K253216
- Product code
- SIN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-06-25
- Date received
- 2025-09-29
- Regulation
- 888.3070
- Classification name
- Automated Intraoperative Spinal Rod Bending System
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Unnati Bhuptani
- Address
- 1950 Camino Vida Roble Carlsbad CA US 92008 92008
FDA Registration Numbers#
- 3019878714
- 2027467