FDA.reportPublic FDA data

ZAVATION SCREW

Primary DI
00197157121068
Brand
ZAVATION SCREW
Company
Zavation LLC
Model
1010-C-045055-C-C
Device description
POLYAXIAL SCREW, CLOSED, TIGER 2 DEFORMITY, 4.5x55, CANNULATED, CORTICAL-CANCELLOUS THREAD
Published
2026-10-15
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
00197157121068PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197157121068001971571210681971571210680197157121068

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.

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
00197157120962ZAVATION SCREW1010-C-045095-S-S2026-10-15
00197157120979ZAVATION SCREW1010-C-045100-S-S2026-10-15
00197157120986ZAVATION SCREW1010-C-045105-S-S2026-10-15
00197157120993ZAVATION SCREW1010-C-045110-S-S2026-10-15
00197157121006ZAVATION SCREW1010-C-045025-C-C2026-10-15
00197157121013ZAVATION SCREW1010-C-045030-C-C2026-10-15
00197157121020ZAVATION SCREW1010-C-045035-C-C2026-10-15
00197157121037ZAVATION SCREW1010-C-045040-C-C2026-10-15
00197157121044ZAVATION SCREW1010-C-045045-C-C2026-10-15
00197157121051ZAVATION SCREW1010-C-045050-C-C2026-10-15
00197157121075ZAVATION SCREW1010-C-045060-C-C2026-10-15
00197157121082ZAVATION SCREW1010-C-045065-C-C2026-10-15
00197157121099ZAVATION SCREW1010-C-045070-C-C2026-10-15
00197157121105ZAVATION SCREW1010-C-045075-C-C2026-10-15
00197157121112ZAVATION SCREW1010-C-045080-C-C2026-10-15
00197157121129ZAVATION SCREW1010-C-045085-C-C2026-10-15
00197157121136ZAVATION SCREW1010-C-045090-C-C2026-10-15
00197157121143ZAVATION SCREW1010-C-045095-C-C2026-10-15
00197157121150ZAVATION SCREW1010-C-045100-C-C2026-10-15
00197157121167ZAVATION SCREW1010-C-045105-C-C2026-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157120962ZAVATION SCREWZavation LLCNKB2026-10-15
00197157120979ZAVATION SCREWZavation LLCNKB2026-10-15
00197157120986ZAVATION SCREWZavation LLCNKB2026-10-15
00197157120993ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121006ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121013ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121020ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121037ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121044ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121051ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121075ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121082ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121099ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121105ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121112ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121129ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121136ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121143ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121150ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121167ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121174ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121181ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121198ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121204ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121211ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121228ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121235ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121242ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121259ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121266ZAVATION SCREWZavation LLCNKB2026-10-15