FDA.reportPublic FDA data

ZAVATION SCREW

Primary DI
00197157124854
Brand
ZAVATION SCREW
Company
Zavation LLC
Model
1010-C-085095-S-S
Device description
POLYAXIAL SCREW, CLOSED, TIGER 2 DEFORMITY, 8.5x95, SOLID, STANDARD THREAD
Published
2026-11-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243908000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243908000Tiger 2 SystemZavation Medical Products, LLC2025-02-03NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00197157124854PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197157124854001971571248541971571248540197157124854

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
6019191119info@zavation.com

Regulatory Flags#

DUNS number
069472800
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00197157124335ZAVATION SCREW1010-C-075070-F-C2026-11-03
00197157124342ZAVATION SCREW1010-C-075075-F-C2026-11-03
00197157124359ZAVATION SCREW1010-C-075080-F-C2026-11-03
00197157124366ZAVATION SCREW1010-C-075085-F-C2026-11-03
00197157124373ZAVATION SCREW1010-C-075090-F-C2026-11-03
00197157124380ZAVATION SCREW1010-C-075095-F-C2026-11-03
00197157124397ZAVATION SCREW1010-C-075100-F-C2026-11-03
00197157124403ZAVATION SCREW1010-C-075105-F-C2026-11-03
00197157124410ZAVATION SCREW1010-C-075110-F-C2026-11-03
00197157124427ZAVATION SCREW1010-C-075025-F-S2026-11-03
00197157124434ZAVATION SCREW1010-C-075030-F-S2026-11-03
00197157124441ZAVATION SCREW1010-C-075035-F-S2026-11-03
00197157124458ZAVATION SCREW1010-C-075040-F-S2026-11-03
00197157124465ZAVATION SCREW1010-C-075045-F-S2026-11-03
00197157124472ZAVATION SCREW1010-C-075050-F-S2026-11-03
00197157124489ZAVATION SCREW1010-C-075055-F-S2026-11-03
00197157124496ZAVATION SCREW1010-C-075075-F-S2026-11-03
00197157124502ZAVATION SCREW1010-C-075085-F-S2026-11-03
00197157124519ZAVATION SCREW1010-C-075095-F-S2026-11-03
00197157124526ZAVATION SCREW1010-C-075105-F-S2026-11-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157124618ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124625ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124632ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124649ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124656ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124663ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124670ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124687ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124694ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124700ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124717ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124724ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124731ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124748ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124755ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124762ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124779ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124786ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124793ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124809ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124816ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124823ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124830ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124847ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124861ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124878ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124885ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124892ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124908ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124915ZAVATION SCREWZavation LLCNKB2026-11-04