Solana Surgical, LLC: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Solana Surgical, LLC” (first 2009, latest 2013), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 82 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 | 4 | 54 |
| 2013 | 3 | 179 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KWD | Prosthesis, Toe, Hemi-, Phalangeal | 4 | 4 |
| HWC | Screw, Fixation, Bone | 2 | 2 |
| HRS | Plate, Fixation, Bone | 1 | 1 |
| JDR | Staple, Fixation, Bone | 1 | 1 |
Review panels
- Orthopedic (8)
Most recent Solana Surgical, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K132594 | CROSSCHECK PLATING SYSTEM | HRS | 2013-12-13 | 116 |
| K131187 | LESSER METATARSAL HEAD IMPLANT SYSTEM | KWD | 2013-10-22 | 179 |
| K124045 | FUSEFORCE IMPLANT SYSTEM | JDR | 2013-07-10 | 191 |
| K122738 | GAITWAY IMPLANT SYSTEM, SURGICAL INSTRUMENT SET | HWC | 2012-11-07 | 62 |
| K120390 | SOLAFIX TWIST SCREW IMPLANT SYSTEM, SURGICAL INSTRUMENT SET | HWC | 2012-04-10 | 63 |
| K120029 | HEMI PHALANGEAL IMPLANT SURGICAL INSTRUMENT SET | KWD | 2012-02-06 | 33 |
| K113752 | METATARSAL DECOMPRESSION IMPLANT SURGICAL INSTRUMENT SET | KWD | 2012-02-06 | 47 |
| K090127 | METATARSAL DECOMPRESSION IMPLANT, MODEL 100 | KWD | 2009-05-01 | 100 |
Recalls
openFDA lists no recalls under a recalling firm named Solana Surgical, 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.
- Solana, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Solana Surgical, LLC?
FDA lists 8 510(k) clearances under the applicant name “Solana Surgical, LLC” (first 2009, latest 2013), across 4 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 Solana Surgical, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Solana Surgical, LLC is 82 days.
Which FDA product codes appear under Solana Surgical, LLC?
The most frequent FDA product codes under this applicant name are KWD (Prosthesis, Toe, Hemi-, Phalangeal, 4); HWC (Screw, Fixation, Bone, 2); HRS (Plate, Fixation, Bone, 1).
Next steps
- See all 8 Solana Surgical, LLC clearances with predicates and recalls
- Run predicate analysis for product code KWD, Solana Surgical, 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.