Pinnacle Spine Group, LLC: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Pinnacle Spine Group, LLC” (first 2011, latest 2017), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 103 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 |
|---|---|---|
| 2012 | 2 | 66 |
| 2013 | 1 | 159 |
| 2014 | 4 | 116 |
| 2015 | 3 | 71 |
| 2016 | 0 | — |
| 2017 | 1 | 133 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Pinnacle Spine Group, LLC took a median 133 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 98 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 8 | 8 |
| FMF | Syringe, Piston | 3 | 3 |
| NKB | Thoracolumbosacral Pedicle Screw System | 1 | 1 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 1 | 1 |
Review panels
- Orthopedic (10)
- General Hospital (3)
Most recent Pinnacle Spine Group, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K172349 | InFill® Interbody Fusion Device | MAX | 2017-12-14 | 133 |
| K152259 | InFill Interbody Fusion Device | MAX | 2015-11-19 | 100 |
| K151184 | InFill Interbody Fusion Devices | MAX | 2015-07-14 | 71 |
| K150206 | InFill Interbody Fusion Devices | MAX | 2015-04-03 | 64 |
| K143488 | InFill Graft Delivery System | FMF | 2014-12-17 | 9 |
| K141282 | PGS 5.5 MM CANNULATED PEDICLE SCREW | NKB | 2014-12-02 | 200 |
| K140066 | INFILL CERVICAL | ODP | 2014-05-05 | 115 |
| K133721 | INFILL 41-TLIF CONVEX OBLIQUE DEVICE, INFILL 43-TLIF CONTOUR OBLIQUE, INFILL 44-TLIF CONTOUR OBLIQUE AND THE INFILL 60 | MAX | 2014-03-31 | 116 |
| K124012 | INFILL OBLIQUE TLIF DEVICE | MAX | 2013-06-04 | 159 |
| K121476 | INFILL GRAFT DELIVERY SYSTEM | FMF | 2012-08-29 | 103 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Pinnacle Spine Group, 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.
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.
- Pinnacle Co., Ltd. (3 510(k)s)
- Pinnacle Distributors, Inc. (2 510(k)s)
- Pinnacle Intl., Inc. (1 510(k)s)
- Pinnacle Products, Inc. (1 510(k)s)
- Pinnacle Biologics, Inc. (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Pinnacle Spine Group, LLC?
FDA lists 13 510(k) clearances under the applicant name “Pinnacle Spine Group, LLC” (first 2011, latest 2017), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Pinnacle Spine Group, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pinnacle Spine Group, LLC is 103 days.
Which FDA product codes appear under Pinnacle Spine Group, LLC?
The most frequent FDA product codes under this applicant name are MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 8); FMF (Syringe, Piston, 3); NKB (Thoracolumbosacral Pedicle Screw System, 1).
Next steps
- See all 13 Pinnacle Spine Group, LLC clearances with predicates and recalls
- Run predicate analysis for product code MAX, Pinnacle Spine Group, 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.