ZSFab Lumbar Surgical Instrument

GUDID 00810136252484

Curette-Right

Zsfab, Inc.

Metallic spinal interbody fusion cage
Primary Device ID00810136252484
NIH Device Record Key686f2f8d-69b1-4fbc-bc3f-a011800fa381
Commercial Distribution StatusIn Commercial Distribution
Brand NameZSFab Lumbar Surgical Instrument
Version Model NumberCurette-Right
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 Identifiers

Device Issuing AgencyDevice ID
GS100810136252484 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810136252484]

Moist Heat or Steam Sterilization

[00810136252484]

Moist Heat or Steam Sterilization

[00810136252484]

Moist Heat or Steam Sterilization

[00810136252484]

Moist Heat or Steam Sterilization

[00810136252484]

Moist Heat or Steam Sterilization

[00810136252484]

Moist Heat or Steam Sterilization

[00810136252484]

Moist Heat or Steam Sterilization

[00810136252484]

Moist Heat or Steam Sterilization

[00810136252484]

Moist Heat or Steam Sterilization

[00810136252484]

Moist Heat or Steam Sterilization

[00810136252484]

Moist Heat or Steam Sterilization

[00810136252484]

Moist Heat or Steam Sterilization

[00810136252484]

Moist Heat or Steam Sterilization

[00810136252484]

Moist Heat or Steam Sterilization

[00810136252484]

Moist Heat or Steam Sterilization

[00810136252484]

Moist Heat or Steam Sterilization

[00810136252484]

Moist Heat or Steam Sterilization

[00810136252484]

Moist Heat or Steam Sterilization

[00810136252484]

Moist Heat or Steam Sterilization

[00810136252484]

Moist Heat or Steam Sterilization

[00810136252484]

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 Lumbar Surgical Instrument]

00810136253207Cage Inserter Caddy
00810136252774Wrench
00810136252767Periosteum Peeler
00810136252750Paddle Distractor-8mm
00810136252743Bone Reamer-14mm
00810136252736Paddle Distractor-9mm
00810136252729Paddle Distractor-10mm
00810136252712Paddle Distractor-11mm
00810136252705Paddle Distractor-12mm
00810136252699Paddle Distractor-13mm
00810136252682Paddle Distractor-14mm
00810136252675Nerve Root Retractor-Small
00810136252668Nerve Root Retractor-Large
00810136252651Trial 8
00810136252644Trial 10
00810136252637Trial 12
00810136252620Trial 14
00810136252613Quick Connect T-handle
00810136252606Implant Support
00810136252590Slap Hammer
00810136252583Ring Graft Impactor
00810136252576Tamp
00810136252569Reamer-Small
00810136252552Graft Funnel
00810136252545Reamer-Medium Small
00810136252538Reamer-Medium
00810136252521Reamer-Large
00810136252514Cage Inserter
00810136252507Scraper
00810136252491Curette-Left
00810136252484Curette-Right
00810136252194Bone Reamer-8mm
00810136252187Bone Reamer-9mm
00810136252170Bone Reamer-10mm
00810136252163Bone Reamer-11mm
00810136252156Bone Reamer-12mm
00810136252149Bone Reamer-13mm
00810136252132Nerve Root Retractor-6mm
00810136252125Nerve Root Retractor-8mm
00810136252118Nerve Root Retractor-10mm
00810136252101Quick Connect T-handle
00810136252095Ring Graft Impactor
00810136252088Osteotome
00810136252071Slap Hammer
00810136252064Ring Curette
00810136252057Curved Graft Impactor
00810136252040Bent Curetee-Left
00810136252033Bent Curetee-Right
00810136252026Square Curette
00810136252019Straight Rasp
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