Spinal Kinetics, LLC: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Spinal Kinetics, LLC” (first 2022, latest 2022), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 70 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2022 | 1 | 70 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Spinal Kinetics, LLC took a median 70 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 59 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MJO | Prosthesis, Intervertebral Disc | 1 | 0 |
| QLQ | Manual Instruments Designed For Use With Total Disc Replacement Devices | 1 | 1 |
Review panels
- Orthopedic (2)
Most recent Spinal Kinetics, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K220861 | M6-C Artificial Cervical Disc Instruments AS | QLQ | 2022-06-02 | 70 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P170036 | PMA | M6-C Artificial Cervical Disc | 2019-02-06 |
Recalls
openFDA lists no recalls under a recalling firm named Spinal Kinetics, LLC.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Spinal Kinetics, LLC is the lead sponsor of 1 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT04122248: M6-C Post Approval Study (PAS) (Active not recruiting, started 2019-11-30)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Spinal Elements, Inc. (50 510(k)s)
- Spinal Concepts, Inc. (33 510(k)s)
- Spinal USA (24 510(k)s)
- Spinal Simplicity, LLC (16 510(k)s)
- Spinal Specialties, Inc. (8 510(k)s)
- Spinal Innovations, LLC (5 510(k)s)
- Spinal Resources, Inc. (4 510(k)s)
- Spinal Edge, LLC (3 510(k)s)
- Spinal Analytics & Geometrical Implant Co, LLC (2 510(k)s)
- Spinal Balance, Inc. (2 510(k)s)
- Spinal Devices, LLC (2 510(k)s)
- Spinal Acoustics, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Spinal Kinetics, LLC?
FDA lists 1 510(k) clearance under the applicant name “Spinal Kinetics, LLC” (first 2022, latest 2022), plus 1 PMA decision, across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Spinal Kinetics, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Spinal Kinetics, LLC is 70 days.
Which FDA product codes appear under Spinal Kinetics, LLC?
The most frequent FDA product codes under this applicant name are MJO (Prosthesis, Intervertebral Disc, 1); QLQ (Manual Instruments Designed For Use With Total Disc Replacement Devices, 1).
Next steps
- See all 1 Spinal Kinetics, LLC clearances with predicates and recalls
- Run predicate analysis for product code MJO, Spinal Kinetics, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.