News & Events

Latest News & Client Successes

510(k) Submissions

clock reading Time is MoneyEmpirical Technologies Corp. is proud to be the leader in submitting 510(k)s for our clients. The Empirical name is on more FDA cleared 510(k) submissions than any other regulatory consulting company. More than 67% of our submissions are accepted without RTA with an average of 106 days to clearance. Recently, we have had submissions clear in as little as 57 days! 

Empirical is also leading the way to assist with COVID-19 related submissions. Contact us about your next project and let us help you get it cleared FAST.

Request An Estimate

Learn more about our Regulatory Services 

Spineex Saggitae 510(k) Cleared 33 Days


Empirical Technologies Corp. is proud to announce the 510(k) clearance of Sagittae® by SpineEx, Inc. in just 33 days!

We love to share our client's success with the world and SpineEx, Inc. continues to be a valued partner.Huge thanks to our Empirical Team members: Meredith May, Nathan Wright, and Susan Holmes for their great teamwork.

Here is what Andrew Rogers of SpineEx, Inc. had to say about our Team:

"The Empirical Team has once again proven instrumental to our business and RA/QA efforts by assisting us with yet another successful 510(k) submission and clearance!"

Read more about Sagittae® Here

For more information about Sagittae®, please contact your SpineEX representative, or email:

SpineEX, Inc.
4046 Clipper Court
Fremont, CA 94538 USA

Accufix Surgical Inc. 510(k)
The Empirical team is proud of the 510(k) submission for Accufix Surgical Inc.'s  Accu-Joint Hemi Implant. This clearance was recently highlighted in Orthoworld's Bonezone publication.

Bonezone - Jan. 25, 2021 - FDA 510(k) Recap 

Cleared Dec. 2020

“The entire Empirical team worked diligently and with the highest level of competence and professionalism. The Accufix Surgical Inc. team looks forward to working on other projects with ETC.”  -  Michael Parisi - Accufix Surgical Inc.

Integrity Implants Inc. 510(k) Cleared 17 Days
Congratulations to Integrity Implants Inc. on an amazing clearance in only 17 days!

Cleared Dec. 2020

"Empirical has been a knowledgeable and responsive extension of our Regulatory Affairs team. We are looking forward to our future collaborations." - Sr. Engineer at Integrity Implants Inc.


Due to COVID-19, thousands of orthopedic patients have experienced a sudden cancellation of scheduled hip, knee, shoulder, extremity, and spine surgeries, as well as physical therapy sessions. These patients will be forced to endure their pain and limited mobility for an indefinite amount of time. Surgeons, physical therapists and engineers in the orthopedic community are challenging themselves and the public to rapidly deliver innovative products, services, and software that can bring relief.
NovApproach Spine’s CEO, Raymond Cloutier, is sponsoring the For Such A Time As This—OrthoChallenge to help expedite introduction of new product, software, and services that address the needs of orthopedic patients whose surgeries and therapies are delayed. The top 10 ideas will be presented to the Food & Drug Administration and other government leaders to help “fast track” these innovations to patients.
The new product, software, or service ideas will help orthopedic patients with their pain and limitations while they wait for surgery and reduce the COVID-19 risks unique to orthopedic patients.

Full Press Release: PRESS RELEASE-ForSuchATImeAsThis-Ortho-Public 8Apr2020 FINAL

Submissions window has closed.

Upcoming Events


Empirical Technologies Corp. is excited to exhibit again at the 2021 AAOS Annual Meeting in San Diego, California  September 1-3, 2021. Our team members will be there to collaborate with you on your next project.                       Click Here To Set An Appt.

We Are Exhibiting at Rapid + tct!

RAPID + TCT is North America’s largest and most important additive manufacturing event in Chicago, IL. September 13-15, 2021​. Our team members will be there to collaborate with you on your next project.                  Click Here To Set An Appt.

Stop By Our Exhibit At NASS 2021!

Our team members will be there to collaborate with you on your next project.                   Click Here To Set An Appt.