Tyber Medical BioTy(TM) Nanotopography Trauma Screw, TyFix Screw

Screw, Fixation, Bone

Tyber Medical, LLC

The following data is part of a premarket notification filed by Tyber Medical, Llc with the FDA for Tyber Medical Bioty(tm) Nanotopography Trauma Screw, Tyfix Screw.

Pre-market Notification Details

• Device ID: K170571
• 510k Number: K170571
• Device Name: Tyber Medical BioTy(TM) Nanotopography Trauma Screw, TyFix Screw
• Classification: Screw, Fixation, Bone
• Applicant: Tyber Medical, LLC 83 S Commerce Way, Suite 310 Bethlehem, PA 18017
• Contact: Mark F. Schenk
• Correspondent: Mark F. Schenk; Tyber Medical, LLC 83 S Commerce Way, Suite 310 Bethlehem, PA 18017
• Product Code: HWC
• CFR Regulation Number: 888.3040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-02-27
• Decision Date: 2017-06-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
M695150020130	K170571	000
M695M13C25015D0	K170571	000
M695M13C20013S0	K170571	000
M695413S30115S0	K170571	000
M695413S301150	K170571	000
M695413S30015S0	K170571	000
M695413S300150	K170571	000
M695413S25115S0	K170571	000
M695413S251150	K170571	000
M695M13C25015S0	K170571	000
M695M13C30015S0	K170571	000
M695M13S30115S0	K170571	000
M695M13S30015S0	K170571	000
M695M13S25115S0	K170571	000
M695M13S25115D0	K170571	000
M695M13S25015S0	K170571	000
M695M13S25015D0	K170571	000
M695M13S20113S0	K170571	000
M695M13S20013S0	K170571	000
M695413S25015S0	K170571	000
M695413S250150	K170571	000
M695150230150	K170571	000
M695150225150	K170571	000
M695150220130	K170571	000
M695150130150	K170571	000
M695150125150	K170571	000
M695150120130	K170571	000
M695150030150	K170571	000
M695150025150	K170571	000
M695413C200130	K170571	000
M695413C20013S0	K170571	000
M695413S20113S0	K170571	000
M695413S201130	K170571	000
M695413S20013S0	K170571	000
M695413S200130	K170571	000
M695413C30015S0	K170571	000
M695413C300150	K170571	000
M695413C25015S0	K170571	000
M695413C250150	K170571	000
M695MMHT25X15C0	K170571	000
M695MMHT25X15S100	K170571	000
B471150120130	K170571	000
B471150030150	K170571	000
B471150030130	K170571	000
B471150025150	K170571	000
B471150025130	K170571	000
B471150020150	K170571	000
B471150020130	K170571	000
00840118114110	K170571	000
B471150120150	K170571	000
B471150125130	K170571	000
B471150230130	K170571	000
B471150225150	K170571	000
B471150225130	K170571	000
B471150220150	K170571	000
B471150220130	K170571	000
B471150130150	K170571	000
B471150130130	K170571	000
B471150125150	K170571	000
00840118114103	K170571	000
00840118114097	K170571	000
M695RAHT2X13C0	K170571	000
M695RAHT25X15S100	K170571	000
M695RAHT25X15C0	K170571	000
M695MMHT3X15C0	K170571	000
M695MMHT2X15S100	K170571	000
M695MMHT2X15C0	K170571	000
M695MMHT2X13S100	K170571	000
M695MMHT2X13C0	K170571	000
M695RAHT2X13S100	K170571	000
M695RAHT2X15C0	K170571	000
00840118114080	K170571	000
00840118114073	K170571	000
00840118114066	K170571	000
00840118114059	K170571	000
00840118114042	K170571	000
00840118114035	K170571	000
M695RAHT3X15C0	K170571	000
M695RAHT2X15S100	K170571	000
B471150230150	K170571	000