Cedar Surgical, Inc.: FDA clearances and approvals
Cedar Surgical, Inc. has 17 FDA 510(k) clearances (first 1985, latest 1987), across 11 product codes in 3 review panels. Median 510(k) review time: 26 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 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 |
|---|---|---|---|
| GAD | Retractor | 2 | 2 |
| HAO | Instrument, Surgical, Non-Powered | 2 | 2 |
| GDG | Hook, Surgical, General & Plastic Surgery | 1 | 1 |
| GEG | Elevator, Surgical, General & Plastic Surgery | 1 | 1 |
| GZT | Retractor, Self-Retaining, For Neurosurgery | 1 | 1 |
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | 1 | 1 |
| HTJ | Gauge, Depth | 1 | 1 |
| HWA | Impactor | 1 | 1 |
| HXR | Spatula, Orthopedic | 1 | 1 |
| LWG | Surgical Table Cushion | 1 | 1 |
Plus 1 more product codes.
Review panels
- General and Plastic Surgery (6)
- Neurology (4)
- Orthopedic (2)
Most recent Cedar Surgical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K873692 | RAYLOR(TM) DRILL STOP | HBE | 1987-12-17 | 100 |
| K872281 | RAYLOR FUSION FUNNEL | HXR | 1987-11-02 | 139 |
| K873690 | CEDAR(TM) PELVIC CUSHION | LWG | 1987-10-26 | 48 |
| K873691 | CEDAR(TM) RETRACTOR RING | GZT | 1987-09-28 | 20 |
| K864425 | RAYLOR(TM) DISSECTING HOOK | GDG | 1986-12-12 | 32 |
| K864426 | RAYLOR(TM) DEPTH GAUGE | HTJ | 1986-11-26 | 16 |
| K864424 | RAYLOR(TM) PROTECTIVE RETRACTOR | GAD | 1986-11-26 | 16 |
| K864421 | RAYLOR(TM) PERIOSTEAL ELEVATORS | GEG | 1986-11-26 | 16 |
| K864423 | RAYLOR(TM) OSTEOTOMES | — | 1986-11-24 | 14 |
| K864422 | RAYLOR(TM) MALLET | HWA | 1986-11-24 | 14 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Cedar Surgical, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Cedar Surgical, Inc. have?
Cedar Surgical, Inc. has 17 FDA 510(k) clearances (first 1985, latest 1987), across 11 product codes in 3 review panels.
How long does FDA take to clear Cedar Surgical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Cedar Surgical, Inc.'s cleared 510(k)s is 26 days.
What devices does Cedar Surgical, Inc. make?
Its most frequent FDA product codes are GAD (Retractor, 2); HAO (Instrument, Surgical, Non-Powered, 2); GDG (Hook, Surgical, General & Plastic Surgery, 1).
Has Cedar Surgical, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Cedar Surgical, Inc. Related entities may recall under other names.
Next steps
- See all 17 Cedar Surgical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GAD, Cedar Surgical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.