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Republic Spine, LLC, Boca Raton, FL – FDA Inspections

Inspection records and compliance data for Republic Spine, LLC in Boca Raton, Florida. 4 FDA inspections on record, 2 Form 483s, last inspected September 26, 2025.

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Company Profile

This profile covers Republic Spine, LLC based in Boca Raton, Florida, United States.

FDA Inspection History

FDA inspections
4
OAI
0
VAI
1
NAI
3
Form 483s
2
Warning letters
0

First inspected March 14, 2018. Last inspected September 26, 2025.

Most cited issue areas

  • Design control - no procedures1 inspection
  • Design Validation - Risk analysis not performed/inadequate1 inspection
  • Lack of or inadequate complaint procedures1 inspection

FDA inspections (4)

DateResultFDA center(s)Insp. #
September 26, 2025NAIMedical Devices & Rad Health · Postmarket Assurance: Medical Devices1284272
April 3, 2023NAIMedical Devices & Rad Health · Compliance: Devices1201991
August 31, 2021NAIBiologics · Human Cellular, Tissue, and Gene Therapies1150493
March 14, 2018VAIMedical Devices & Rad Health · Compliance: Devices1044363
FDA documents

Form 483s (1)

  • Form 483s · September 26, 2025
People (1)
David M. Wilkinson
Person
Related Companies (10)

Companies with similar regulatory profiles, compliance history, and operations.

Terumo BCT Sterilization Services, Inc.
Thermo Fisher Scientific (Asheville) LLC
Pioneer Surgical Technology Inc.
Park Dental Research Corp
BioAccess, Inc.
Globus Medical, Inc.
Viant San Antonio, Inc.
Vascular Solutions, Inc.
Nexxt Spine, LLC
Impladent Ltd.
Company Information

Name

Republic Spine, LLC

FEI Number

3011796723

Address

2424 N Federal Hwy Ste 257, Boca Raton, Florida 33431, United States

Country

United States

ID: 6aecb05b-1617-4ebf-ad03-d5e16c531368

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