Zavation Modular Screw

GUDID 00842166194809

Modular Screw 8.5x110

Zavation LLC

Orthopaedic bone screw (non-sliding)
Primary Device ID00842166194809
NIH Device Record Keyd01bd286-d82f-4bda-86fb-d10ad73caaff
Commercial Distribution StatusIn Commercial Distribution
Brand NameZavation Modular Screw
Version Model Number383-85110-S
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 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

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
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
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
Phone6019191119
Emailinfo@zavation.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100842166194809 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00842166194809]

Moist Heat or Steam Sterilization

[00842166194809]

Moist Heat or Steam Sterilization

[00842166194809]

Moist Heat or Steam Sterilization

[00842166194809]

Moist Heat or Steam Sterilization

[00842166194809]

Moist Heat or Steam Sterilization

[00842166194809]

Moist Heat or Steam Sterilization

[00842166194809]

Moist Heat or Steam Sterilization

[00842166194809]

Moist Heat or Steam Sterilization

[00842166194809]

Moist Heat or Steam Sterilization

[00842166194809]

Moist Heat or Steam Sterilization

[00842166194809]

Moist Heat or Steam Sterilization

[00842166194809]

Moist Heat or Steam Sterilization

[00842166194809]

Moist Heat or Steam Sterilization

[00842166194809]

Moist Heat or Steam Sterilization

[00842166194809]

Moist Heat or Steam Sterilization

[00842166194809]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-20
Device Publish Date2024-11-12

Devices Manufactured by Zavation LLC

00197157071400 - ZAVATION ROD BENDER2025-09-23 INSITU BENDER - RIGHT 6.0 ROD
00197157071417 - ZAVATION ROD BENDER2025-09-23 INSITU BENDER - LEFT 6.0 ROD
00197157071455 - ZAVATION CADDY2025-09-23 TIGER 2 DEFORMITY IMPLANTS - HOOKS CADDY
00197157071462 - ZAVATION CADDY2025-09-23 TIGER 2 DEFORMITY IMPLANTS - FRACTURE SCREW CADDY (STANDARD OR CANNULATED)
00197157071479 - ZAVATION CADDY2025-09-23 TIGER 2 DEFORMITY IMPLANTS - FRACTURE SCREW- STANDARD LID
00197157071486 - ZAVATION CADDY2025-09-23 TIGER 2 DEFORMITY IMPLANTS - FRACTURE SCREW- CANNULATED LID
00197157071493 - ZAVATION CADDY2025-09-23 TIGER 2 DEFORMITY IMPLANTS - BIASED ANGLE SCREW CADDY (STANDARD OR REDUCTION)
00197157071509 - ZAVATION CADDY LID2025-09-23 TIGER 2 DEFORMITY IMPLANTS - BIASED ANGLE SCREW CADDY LID
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