Momentum Spine
FDA 510(k) clearance K232023 · decided 2023-10-04
Clearance details
- K-number
- K232023
- Device name
- Momentum Spine
- Applicant
- Momentum Health, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-07-07
- Decision date
- 2023-10-04
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- LDK
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Montreal, CA
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| NSite Scoliosis Assessment App (K230463) | Nsite, Inc. | 2023-11-15 |
| CryoVizion System (K183485) | Cryos Technologies, Inc. | 2019-08-28 |
| QUANTEC SPINAL MEASUEMENT SYSTEM (K923792) | Quantec Image Processing , Ltd. | 1994-04-20 |
| METRICOM (K860225) | Far Orthopedics, Inc. | 1986-02-11 |
| TERRAN BIOMECHANICAL ANALYSIS SYSTEM (K851133) | Terran Biomedical Instruments | 1985-06-19 |
| ISIS (K844736) | Oxford Medilog, Inc. | 1985-03-21 |
| CONTOUROGRAPH M-500 (K800591) | Bio-Tek Instruments, Inc. | 1980-04-02 |
Recalls involving this device
No recalls on record reference this clearance.