Bodycad Laboratories Inc

FDA Filings

This page includes the latest FDA filings for Bodycad Laboratories Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Bodycad Laboratories Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• BODYCAD LABORATORIES, INC.

FDA Registration(s)

• Registration Number: 3012086398
• FEI Number: 3012086398
• Name: BODYCAD LABORATORIES, INC.
• Owner & Operator: Bodycad Laboratories, Inc.
• Contact Address: 2035 rue du Haut-Bord ; Qu?bec CA-QC Quebec G1N 4R7 CA
• Official Correspondent:
  • Guy Sevigny
  • 1-418-5271388-x
• US Agent:
  • Stephen Herrington
  • Bodycad Laboratories Inc.
  • 239 8777069
  • stephen@bodycad.com
• Importing Logistics Registration:
  • Importer: Bodycad USA Corp.
  • Address: 5935 BARCLAY LANE ; Naples, FL 34110 UNITED STATES
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2035 rue du Haut-Bord ; Quebec Quebec, G1N 4R7 CA
• Establishment Type:
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
PMN K212307 Bodycad Laboratories, Inc.	BC Reflex Uni Knee System	2021-10-12
PMN K211895 Bodycad Laboratories, Inc.	BC Reflex Uni Knee System	2021-08-20
PMN K211646 Bodycad Laboratories, Inc.	FINE Osteotomy	2021-07-28
PMN K203697 Bodycad Laboratories, Inc.	BC Reflex Uni Knee System	2021-03-12
PMN K193614 | PBF BODYCAD LABORATORIES, INC.	Fine Osteotomy	2020-04-06
PMN K193614 | HWC BODYCAD LABORATORIES, INC.	Fine Osteotomy	2020-04-06
PMN K193614 | HRS BODYCAD LABORATORIES, INC.	Fine Osteotomy	2020-04-06
PMN K193614 Bodycad Laboratories, Inc.	FINE Osteotomy Around The Knee	2020-03-25
PMN K191996 | HSX BODYCAD LABORATORIES, INC.	BC Reflex Uni	2019-12-19
PMN K191996 Bodycad Laboratories, Inc.	BC Reflex Uni Knee System	2019-12-05
PMN K191150 | HSX BODYCAD LABORATORIES, INC.	Bodycad Unicompartmental Knee System	2019-10-28
PMN K181302 | HSX BODYCAD LABORATORIES, INC.	Bodycad Unicompartmental Knee System	2019-10-28
PMN K191150 Bodycad Laboratories, Inc.	Bodycad Unicompartmental Knee System	2019-10-08
PMN K181302 Bodycad Laboratories Inc.	Bodycad Unicompartmental Knee System	2019-01-17
PMN K163700 Bodycad Laboratories, Inc.	Bodycad Unicompartmental Knee System	2017-03-29
PMN K163700 | HSX BODYCAD LABORATORIES, INC.	Bodycad Unicompartmental Knee System	2017-03-29
FZX BODYCAD LABORATORIES, INC.	Bodycad OnCall Cutting Guides	2016-12-13
LXH BODYCAD LABORATORIES, INC.	Bodycad	2016-02-29