Black Diamond™ POCT Spinal System

Posterior Cervical Screw System

Osseus Fusion Systems

The following data is part of a premarket notification filed by Osseus Fusion Systems with the FDA for Black Diamond™ Poct Spinal System.

Pre-market Notification Details

• Device ID: K222107
• 510k Number: K222107
• Device Name: Black Diamond™ POCT Spinal System
• Classification: Posterior Cervical Screw System
• Applicant: Osseus Fusion Systems 1931 Greenville Ave Suite 200 Dallas, TX 75206
• Contact: Jonathan Rosen
• Correspondent: Daniel Johnson; Jalex Medical LLC 27865 Clemens Rd Suite 3 Westlake, OH 44145
• Product Code: NKG
• CFR Regulation Number: 888.3075 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2022-07-18
• Decision Date: 2022-11-03

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B06224200000	K222107	000
B06224200070	K222107	000
B06224200075	K222107	000
B06224200080	K222107	000
B06224200085	K222107	000
B06224200090	K222107	000
B06224200095	K222107	000
B06224200100	K222107	000
B06224200105	K222107	000
B06224200110	K222107	000
B06224200065	K222107	000
B06224200060	K222107	000
B06224200001	K222107	000
B06224200002	K222107	000
B06224200025	K222107	000
B06224200030	K222107	000
B06224200035	K222107	000
B06224200040	K222107	000
B06224200045	K222107	000
B06224200050	K222107	000
B06224200055	K222107	000
B06224200115	K222107	000
B06224200120	K222107	000
B06224203520	K222107	000
B06224203522	K222107	000
B06224204524	K222107	000
B06224204526	K222107	000
B06224204528	K222107	000
B06224204530	K222107	000
B06224204532	K222107	000
B06224204534	K222107	000
B06224204536	K222107	000
B06224203518	K222107	000
B06224203516	K222107	000
B06224200130	K222107	000
B06224200140	K222107	000
B06224200150	K222107	000
B06224200160	K222107	000
B06224201150	K222107	000
B06224203509	K222107	000
B06224203510	K222107	000
B06224203512	K222107	000
B06224203514	K222107	000
B06224204538	K222107	000