ZAVATION CADDY

GUDID 00197157015350

TIGER 2, CADDY, Ø 6.0MM LONG RODS

Zavation LLC

Instrument tray, reusable
Primary Device ID00197157015350
NIH Device Record Key36ce106b-0ef9-4e84-a5b7-0301613773b0
Commercial Distribution StatusIn Commercial Distribution
Brand NameZAVATION CADDY
Version Model Number14G00831
Company DUNS069472800
Company NameZavation LLC
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 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

Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com
Phone6019191119
Emailinfo@zavation.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100197157015350 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00197157015350]

Moist Heat or Steam Sterilization

[00197157015350]

Moist Heat or Steam Sterilization

[00197157015350]

Moist Heat or Steam Sterilization

[00197157015350]

Moist Heat or Steam Sterilization

[00197157015350]

Moist Heat or Steam Sterilization

[00197157015350]

Moist Heat or Steam Sterilization

[00197157015350]

Moist Heat or Steam Sterilization

[00197157015350]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-12
Device Publish Date2025-06-04

On-Brand Devices [ZAVATION CADDY]

00197157015367TIGER 2, CADDY, LATERAL OFFSET CONNECTORS
00197157015350TIGER 2, CADDY, Ø 6.0MM LONG RODS
00197157015343TIGER 2, CADDY, Ø 5.5MM LONG RODS
00197157015336TIGER 2, CADDY, Ø 5.5MM RODS & CROSS CONNECTORS
00197157015329TIGER 2, CADDY, REDUCTION IMPLANTS
00197157015312TIGER 2, CADDY, ROD CONNECTOR - CROSS CONNECTORS
00197157015282TIGER 2, CADDY, ROD CONNECTOR - CLOSED
00197157015275TIGER 2, CADDY, ROD CONNECTOR - SIDE LOADING
00197157015213TIGER 2, CADDY, Ø 9.5MM SCREW SHANKS
00197157015206TIGER 2, CADDY, Ø 8.5MM SCREW SHANKS
00197157015190TIGER 2, CADDY, Ø 7.5MM SCREW SHANKS
00197157015183TIGER 2, CADDY, Ø 6.5MM SCREW SHANKS
00197157015176TIGER 2, CADDY, Ø 5.5MM SCREW SHANKS
00197157015169TIGER 2, CADDY, Ø 4.5MM SCREW SHANKS
00197157015152TIGER 2, CADDY, SACROILLIAC SHANKS
00197157015145TIGER 2, CADDY, STANDARD SHANKS, TULIPS, AND LOCKING SCREWS
00197157015138TIGER 2, CADDY, Ø 6.0MM RODS
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.