Arc Surgical, LLC: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Arc Surgical, LLC” (first 2005, latest 2015), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 189 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 260 |
| 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 |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | 3 | 3 |
| HAW | Neurological Stereotaxic Instrument | 1 | 1 |
| HTY | Pin, Fixation, Smooth | 1 | 1 |
Review panels
- Orthopedic (4)
- Neurology (1)
Most recent Arc Surgical, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K141559 | V-GUIDE FOR VENTRICULOSTOMIES | HAW | 2015-02-27 | 260 |
| K071616 | ARC SURGICAL BIOTRAK PIN SYSTEM | HTY | 2007-12-19 | 189 |
| K063244 | ARC SURGICAL BONE REDUCTION SCREW | HWC | 2006-12-27 | 62 |
| K061763 | ARC SURGICAL BIOTRAK SCREW | HWC | 2006-09-19 | 89 |
| K043176 | ARC SURGICAL RESORBABLE COMPRESSION SCREW SYSTEM | HWC | 2005-06-17 | 213 |
Recalls
openFDA lists no recalls under a recalling firm named Arc 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Arc Surgical, LLC?
FDA lists 5 510(k) clearances under the applicant name “Arc Surgical, LLC” (first 2005, latest 2015), across 3 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 Arc Surgical, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Arc Surgical, LLC is 189 days.
Which FDA product codes appear under Arc Surgical, LLC?
The most frequent FDA product codes under this applicant name are HWC (Screw, Fixation, Bone, 3); HAW (Neurological Stereotaxic Instrument, 1); HTY (Pin, Fixation, Smooth, 1).
Next steps
- See all 5 Arc Surgical, LLC clearances with predicates and recalls
- Run predicate analysis for product code HWC, Arc 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.