FDA.reportPublic FDA data

ZAVATION SCREW

Primary DI
00197157125578
Brand
ZAVATION SCREW
Company
Zavation LLC
Model
1010-C-095040-S-C
Device description
POLYAXIAL SCREW, CLOSED, TIGER 2 DEFORMITY, 9.5x40, SOLID, CORTICAL-CANCELLOUS THREAD
Published
2026-11-05
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
00197157125578PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197157125578001971571255781971571255780197157125578

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
00197157125325ZAVATION SCREW1010-C-085060-F-C2026-11-05
00197157125332ZAVATION SCREW1010-C-085065-F-C2026-11-05
00197157125349ZAVATION SCREW1010-C-085070-F-C2026-11-05
00197157125356ZAVATION SCREW1010-C-085075-F-C2026-11-05
00197157125363ZAVATION SCREW1010-C-085080-F-C2026-11-05
00197157125370ZAVATION SCREW1010-C-085085-F-C2026-11-05
00197157125387ZAVATION SCREW1010-C-085090-F-C2026-11-05
00197157125394ZAVATION SCREW1010-C-085095-F-C2026-11-05
00197157125400ZAVATION SCREW1010-C-085100-F-C2026-11-05
00197157125417ZAVATION SCREW1010-C-085105-F-C2026-11-05
00197157125424ZAVATION SCREW1010-C-085110-F-C2026-11-05
00197157125448ZAVATION SCREW1010-C-085030-F-S2026-11-05
00197157125455ZAVATION SCREW1010-C-085035-F-S2026-11-05
00197157125462ZAVATION SCREW1010-C-085040-F-S2026-11-05
00197157125479ZAVATION SCREW1010-C-085045-F-S2026-11-05
00197157125486ZAVATION SCREW1010-C-085050-F-S2026-11-05
00197157125493ZAVATION SCREW1010-C-085055-F-S2026-11-05
00197157125509ZAVATION SCREW1010-C-085075-F-S2026-11-05
00197157125516ZAVATION SCREW1010-C-085085-F-S2026-11-05
00197157125523ZAVATION SCREW1010-C-085095-F-S2026-11-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157125325ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125332ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125349ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125356ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125363ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125370ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125387ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125394ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125400ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125417ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125424ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125448ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125455ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125462ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125479ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125486ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125493ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125509ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125516ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125523ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125530ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125547ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125554ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125561ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125585ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125592ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125608ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125615ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125622ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125639ZAVATION SCREWZavation LLCNKB2026-11-05