ZSFab Cervical Surgical Instrument

GUDID 00810136251043

Trial 12*14mm,10°-9

Zsfab, Inc.

Metallic spinal interbody fusion cage
Primary Device ID00810136251043
NIH Device Record Key905c3190-e914-42c6-9603-17c2a5f57185
Commercial Distribution StatusIn Commercial Distribution
Brand NameZSFab Cervical Surgical Instrument
Version Model Number12140910
Company DUNS105224126
Company NameZsfab, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Depth12 Millimeter
Width14 Millimeter
Height9 Millimeter
Angle10 degree
Depth12 Millimeter
Width14 Millimeter
Height9 Millimeter
Angle10 degree
Depth12 Millimeter
Width14 Millimeter
Height9 Millimeter
Angle10 degree
Depth12 Millimeter
Width14 Millimeter
Height9 Millimeter
Angle10 degree
Depth12 Millimeter
Width14 Millimeter
Height9 Millimeter
Angle10 degree
Depth12 Millimeter
Width14 Millimeter
Height9 Millimeter
Angle10 degree
Depth12 Millimeter
Width14 Millimeter
Height9 Millimeter
Angle10 degree
Depth12 Millimeter
Width14 Millimeter
Height9 Millimeter
Angle10 degree
Depth12 Millimeter
Width14 Millimeter
Height9 Millimeter
Angle10 degree
Depth12 Millimeter
Width14 Millimeter
Height9 Millimeter
Angle10 degree
Depth12 Millimeter
Width14 Millimeter
Height9 Millimeter
Angle10 degree
Depth12 Millimeter
Width14 Millimeter
Height9 Millimeter
Angle10 degree
Depth12 Millimeter
Width14 Millimeter
Height9 Millimeter
Angle10 degree
Depth12 Millimeter
Width14 Millimeter
Height9 Millimeter
Angle10 degree
Depth12 Millimeter
Width14 Millimeter
Height9 Millimeter
Angle10 degree
Depth12 Millimeter
Width14 Millimeter
Height9 Millimeter
Angle10 degree
Depth12 Millimeter
Width14 Millimeter
Height9 Millimeter
Angle10 degree
Depth12 Millimeter
Width14 Millimeter
Height9 Millimeter
Angle10 degree

Device Identifiers

Device Issuing AgencyDevice ID
GS100810136251043 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810136251043]

Moist Heat or Steam Sterilization


[00810136251043]

Moist Heat or Steam Sterilization


[00810136251043]

Moist Heat or Steam Sterilization


[00810136251043]

Moist Heat or Steam Sterilization


[00810136251043]

Moist Heat or Steam Sterilization


[00810136251043]

Moist Heat or Steam Sterilization


[00810136251043]

Moist Heat or Steam Sterilization


[00810136251043]

Moist Heat or Steam Sterilization


[00810136251043]

Moist Heat or Steam Sterilization


[00810136251043]

Moist Heat or Steam Sterilization


[00810136251043]

Moist Heat or Steam Sterilization


[00810136251043]

Moist Heat or Steam Sterilization


[00810136251043]

Moist Heat or Steam Sterilization


[00810136251043]

Moist Heat or Steam Sterilization


[00810136251043]

Moist Heat or Steam Sterilization


[00810136251043]

Moist Heat or Steam Sterilization


[00810136251043]

Moist Heat or Steam Sterilization


[00810136251043]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-20
Device Publish Date2025-05-12

On-Brand Devices [ZSFab Cervical Surgical Instrument]

00810136251944Trails caddy B
00810136251937Trail caddy A
00810136251920Cervical interbody sterilization case B
00810136251913Cervical interbody sterilization case A
00810136251906Trial 16*18mm,20°-12
00810136251890Trial 16*18mm,20°-11
00810136251883Trial 16*18mm,20°-10
00810136251876Trial 16*18mm,20°-9
00810136251869Trial 16*18mm,20°-8
00810136251852Trial 16*18mm,15°-12
00810136251845Trial 16*18mm,15°-11
00810136251838Trial 16*18mm,15°-10
00810136251821Trial 16*18mm,15°-9
00810136251814Trial 16*18mm,15°-8
00810136251807Trials 16*18mm,15°-7
00810136251791Trial 16*18mmm,10°-12
00810136251784Trial 16*18mmm,10°-11
00810136251777Trial 16*18mmm,10°-10
00810136251760Trial 16*18mmm,10°-9
00810136251753Trial 16*18mmm,10°-8
00810136251746Trial 16*18mmm,10°-7
00810136251739Trial 16*18mmm,10°-6
00810136251722Trial 16*18mm,7°-12
00810136251715Trial 16*18mm,7°-11
00810136251708Trial 16*18mm,7°-10
00810136251692Trial 16*18mm,7°-9
00810136251685Trial 16*18mm,7°-8
00810136251678Trial 16*18mm,7°-7
00810136251661Trial 16*18mm,7°-6
00810136251654Trial 16*18mm,7°-5
00810136251647Trial 16*18mm,0°-12
00810136251630Trial 16*18mm,0°-11
00810136251623Trial 16*18mm,0°-10
00810136251616Trial 16*18mm,0°-9
00810136251609Trial 16*18mm,0°-8
00810136251593Trial 16*18mm,0°-7
00810136251586Trial 16*18mm,0°-6
00810136251579Trial 16*18mm,0°-5
00810136251562Trial 14*16mm,20°-12
00810136251555Trial 14*16mm,20°-11
00810136251548Trial 14*16mm,20°-10
00810136251531Trial 14*16mm,20°-9
00810136251524Trial 14*16mm,20°-8
00810136251517Trial 14*16mm,15°-12
00810136251500Trial 14*16mm,15°-11
00810136251494Trial 14*16mm,15°-10
00810136251487Trial 14*16mm,15°-9
00810136251470Trial 14*16mm,15°-8
00810136251463Trial 14*16mm,15°-7
00810136251456Trial 14*16mm,15°-6

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