510(k) K232023
- Device
- Momentum Spine
- Applicant
- Momentum Health, Inc.
- 510(k) number
- K232023
- Product code
- LDK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-10-04
- Date received
- 2023-07-07
- Classification name
- Device, Sensing, Optical Contour
- Medical specialty
- Unknown
- Review panel
- Unknown
- Device class
- U
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Evan Dimentberg
- Address
- 2727 Rue St-Patrick, Apt.109 Montreal CA H3K0A8 H3K0A8
FDA Registration Numbers#
- 3029900922
Source Documents#
Other 510(k) Records For Product Code LDK#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K230463 | NSite Scoliosis Assessment App | Nsite, Inc. | 2023-11-15 |
| K183485 | CryoVizion System | Cryos Technologies, Inc. | 2019-08-28 |
| K923792 | QUANTEC SPINAL MEASUEMENT SYSTEM | Quantec Image Processing , Ltd. | 1994-04-20 |
| K860225 | METRICOM | Far Orthopedics, Inc. | 1986-02-11 |
| K851133 | TERRAN BIOMECHANICAL ANALYSIS SYSTEM | Terran Biomedical Instruments | 1985-06-19 |
| K844736 | ISIS | Oxford Medilog, Inc. | 1985-03-21 |
| K800591 | CONTOUROGRAPH M-500 | Bio-Tek Instruments, Inc. | 1980-04-02 |