Cannulated Compression Headless Screw 1ZB503105

GUDID 00810030821205

5.0 HDLS CANN LNG SCR X105

Tyber Medical LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID00810030821205
NIH Device Record Key94cc9f53-3a89-4afa-97af-bfe67f0edac0
Commercial Distribution StatusIn Commercial Distribution
Brand NameCannulated Compression Headless Screw
Version Model Number1ZB503105
Catalog Number1ZB503105
Company DUNS010968002
Company NameTyber Medical LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(866)761-0933
Email[email protected]

Device Identifiers

Device Issuing AgencyDevice ID
GS100810030821205 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810030821205]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-02-11
Device Publish Date2020-01-11

On-Brand Devices [Cannulated Compression Headless Screw]

008199170270759.0MM/2.8MM GUIDE WIRE SLEEVE
0081991702705111.0MM/9.0MM TISSUE PROTECTOR
008199170270447.5MM/1.6MM GUIDE WIRE SLEEVE
008199170270209.5 MM/7.5MM TISSUE PROTECTOR
00819917027013CANN SCRWDRVR HANDLE WITH RATCHET LG QUICK COUPLING
00819917027006CANN SCRWDRVR HANDLE WITH RATCHET QUICK COUPLING
00819917026993CANN SCRWDRVR HANDLE WITH JWLRS CAP QUICK COUPLING
00819917026986DIRECT MEASURING DEVICE FOR 220MM WIRE
00819917026979DIRECT MEASURING DEVICE FOR 150MM WIRE
00819917026962DIRECT MEASURING DEVICE FOR 100MM WIRE
008199170269555.0MM/2.8MM DOUBLE DRILL GUIDE
008199170269483.0MM/1.6MM DOUBLE DRILL GUIDE
008199170269312.7MM/1.4MM DOUBLE DRILL GUIDE
008199170269242.0MM/1.1MM DOUBLE DRILL GUIDE
008199170269171.6MM/0.8MM DOUBLE DRILL GUIDE
00819917026900T30 CANN STRDRV SCRWDRVR SHAFT SLF-RETAIN
00819917026894T15 CANN STRDRV SCRWDRVR SHAFT SLF-RETAIN
00819917026887T8 STRDRV SCRWDRVR SHAFT SLF-RETAIN
00819917026870T8 CANN STRDRV SCRWDRVR SHAFT SLF-RETAIN
00819917026863T6 STRDRV SCRWDRVR SHAFT SLF-RETAIN
00819917026856T6 CANN STRDRV SCRWDRVR SHAFT SLF-RETAIN
00819917026696CANN COUNTERSINK FOR 6.5MM/7.5MM CANN HEADLESS SCREW/LARGE QC
00819917026689CANN COUNTERSINK FOR 4.5MM/5.5MM CANN HEADLESS SCREW/QC
00819917026672CANN COUNTERSINK FOR 3.5MM/4.0MM CANN HEADLESS SCREW/QC
00819917026665CANN COUNTERSINK FOR 2.5MM/3.0MM CANN HEADLESS SCREW/QC
00819917026658CANN COUNTERSINK FOR 2.0MM CANN HEADLESS SCREW/QC
008199170265975.0MM CANN DRILL BIT LARGE QC/ 215MM
008199170265803.0MM CANN DRILL BIT QC/ 215MM
008199170265732.7MM CANN DRILL BIT QC/ 145MM
008199170265662.0MM CANN DRILL BIT QC/ 145MM
008199170265591.6MM CANN DRILL BIT QC/ 95MM
008199170264812.8MM GUIDE WIRE/ 300MM LENGTH FLUTED TIP
008199170264742.8MM GUIDE WIRE/ 220MM LENGTH FLUTED TIP
008199170264671.6MM GUIDE WIRE/ 220MM LENGTH TROCAR TIP
008199170264501.4MM GUIDE WIRE / 150MM LENGTH TROCAR TIP
008199170264431.1MM GUIDE WIRE/ 150MM LENGTH TROCAR TIP
008199170264360.8MM GUIDE WIRE/ 100MM LENGTH TROCAR TIP
008199170264297.5MM TI CANN COMPRESSION HEADLESS SCREW- LT- 140MM
008199170264127.5MM TI CANN COMPRESSION HEADLESS SCREW- LT- 135MM
008199170264057.5MM TI CANN COMPRESSION HEADLESS SCREW- LT- 130MM
008199170263997.5MM TI CANN COMPRESSION HEADLESS SCREW- LT- 125MM
008199170263827.5MM TI CANN COMPRESSION HEADLESS SCREW- LT- 120MM
008199170263757.5MM TI CANN COMPRESSION HEADLESS SCREW- LT- 115MM
008199170263687.5MM TI CANN COMPRESSION HEADLESS SCREW- LT- 110MM
008199170263517.5MM TI CANN COMPRESSION HEADLESS SCREW- LT- 105MM
008199170263447.5MM TI CANN COMPRESSION HEADLESS SCREW- LT- 100MM
008199170263377.5MM TI CANN COMPRESSION HEADLESS SCREW- LT- 95MM
008199170263207.5MM TI CANN COMPRESSION HEADLESS SCREW- LT- 90MM
008199170263137.5MM TI CANN COMPRESSION HEADLESS SCREW- LT- 85MM
008199170263067.5MM TI CANN COMPRESSION HEADLESS SCREW- LT- 80MM

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.