FINE Osteotomy

Plate, Fixation, Bone

Bodycad Laboratories, Inc.

The following data is part of a premarket notification filed by Bodycad Laboratories, Inc. with the FDA for Fine Osteotomy.

Pre-market Notification Details

• Device ID: K211646
• 510k Number: K211646
• Device Name: FINE Osteotomy
• Classification: Plate, Fixation, Bone
• Applicant: Bodycad Laboratories, Inc. 2035, Rue Du Haut-Bord Quebec City, CA G1n 4r7
• Contact: Nadine Adia
• Correspondent: Robert A Poggie; BioVera Inc. 65 Promenade Saint Louis Notre-dame-del-l'ile-perrot, CA J7v 7p2
• Product Code: HRS
• Subsequent Product Code: HWC
• Subsequent Product Code: PBF
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-05-28
• Decision Date: 2021-07-28

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00688346002287	K211646	000
00688346002324	K211646	000
00688346002317	K211646	000
00688346002300	K211646	000
00688346002294	K211646	000
00688346002416	K211646	000
00688346002409	K211646	000
00688346002393	K211646	000
00688346002386	K211646	000
00688346002379	K211646	000
00688346002362	K211646	000
00688346002355	K211646	000
00688346002348	K211646	000
00688346002478	K211646	000
00688346002331	K211646	000
00688346002133	K211646	000
00688346002270	K211646	000
00688346002263	K211646	000
00688346002256	K211646	000
00688346002249	K211646	000
00688346002232	K211646	000
00688346002225	K211646	000
00688346002218	K211646	000
00688346002201	K211646	000
00688346002195	K211646	000
00688346002188	K211646	000
00688346002164	K211646	000
00688346002157	K211646	000
00688346002140	K211646	000
00688346000191	K211646	000