Restor3d Utility Wedge

Bone Wedge

Restor3d, Inc.

The following data is part of a premarket notification filed by Restor3d, Inc. with the FDA for Restor3d Utility Wedge.

Pre-market Notification Details

• Device ID: K201314
• 510k Number: K201314
• Device Name: Restor3d Utility Wedge
• Classification: Bone Wedge
• Applicant: restor3d, Inc. 311 W Corporation St Durham, NC 27701
• Contact: Michaela Pigue
• Correspondent: Michaela Pigue; restor3d, Inc. 311 W Corporation St Durham, NC 27701
• Product Code: PLF
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-05-18
• Decision Date: 2021-06-17

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00840097504933	K201314	000
00840097503257	K201314	000
00840097503264	K201314	000
00840097503271	K201314	000
00840097503288	K201314	000
00840097503295	K201314	000
00840097503301	K201314	000
00840097503318	K201314	000
00840097503325	K201314	000
00840097503332	K201314	000
00840097503349	K201314	000
00840097503240	K201314	000
00840097505046	K201314	000
00840097504940	K201314	000
00840097504957	K201314	000
00840097504964	K201314	000
00840097504971	K201314	000
00840097504988	K201314	000
00840097504995	K201314	000
00840097505008	K201314	000
00840097505015	K201314	000
00840097505022	K201314	000
00840097505039	K201314	000
00840097503356	K201314	000
00840097503363	K201314	000
00840097503493	K201314	000
00840097503509	K201314	000
00840097503516	K201314	000
00840097503523	K201314	000
00840097503530	K201314	000
00840097503547	K201314	000
00840097503554	K201314	000
00840097503561	K201314	000
00840097503578	K201314	000
00840097503585	K201314	000
00840097503486	K201314	000
00840097503479	K201314	000
00840097503370	K201314	000
00840097503387	K201314	000
00840097503394	K201314	000
00840097503400	K201314	000
00840097503417	K201314	000
00840097503424	K201314	000
00840097503431	K201314	000
00840097503448	K201314	000
00840097503455	K201314	000
00840097503462	K201314	000
00840097503592	K201314	000