510(k) K262721
- Device
- Spinalogic Bone Growth Stimulator
- Applicant
- Djo, LLC
- 510(k) number
- K262721
- Product code
- LOF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-09-29
- Date received
- 2026-07-31
- Regulation
- 890.5870
- Classification name
- Stimulator, Bone Growth, Non-Invasive
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Mitchell Dhority
- Address
- 5919 Sea Otter Pl. Carlsbad CA US 92010 92010
FDA Registration Numbers#
- 3030686063
- 3003435252
- 3016050940
- 3007611554
- 3013378804
- 1721293
- 9611854
- 3009595577
- 3009437400
- 3012447612
- 3012446970
- 3017264244
- 2242816
- 3038295706
- 2183449
- 3027669735
- 3010032952