FDA.reportPublic FDA data

ZAVATION SCREW

Primary DI
00197157119768
Brand
ZAVATION SCREW
Company
Zavation LLC
Model
1011-O-105035-C-S
Device description
BIASED ANGLE POLYAXIAL SCREW, OPEN, TIGER 2 DEFORMITY, 10.5x35, CANNULATED, STANDARD THREAD
Published
2026-10-12
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
00197157119768PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197157119768001971571197681971571197680197157119768

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
00197157119638ZAVATION SCREW1011-O-105060-C-C2026-10-12
00197157119645ZAVATION SCREW1011-O-105065-C-C2026-10-12
00197157119652ZAVATION SCREW1011-O-105070-C-C2026-10-12
00197157119669ZAVATION SCREW1011-O-105075-C-C2026-10-12
00197157119676ZAVATION SCREW1011-O-105080-C-C2026-10-12
00197157119683ZAVATION SCREW1011-O-105085-C-C2026-10-12
00197157119690ZAVATION SCREW1011-O-105090-C-C2026-10-12
00197157119706ZAVATION SCREW1011-O-105095-C-C2026-10-12
00197157119713ZAVATION SCREW1011-O-105100-C-C2026-10-12
00197157119720ZAVATION SCREW1011-O-105105-C-C2026-10-12
00197157119737ZAVATION SCREW1011-O-105110-C-C2026-10-12
00197157119744ZAVATION SCREW1011-O-105025-C-S2026-10-12
00197157119751ZAVATION SCREW1011-O-105030-C-S2026-10-12
00197157119775ZAVATION SCREW1011-O-105040-C-S2026-10-12
00197157119782ZAVATION SCREW1011-O-105045-C-S2026-10-12
00197157119799ZAVATION SCREW1011-O-105050-C-S2026-10-12
00197157119805ZAVATION SCREW1011-O-105055-C-S2026-10-12
00197157119812ZAVATION SCREW1011-O-105060-C-S2026-10-12
00197157119829ZAVATION SCREW1011-O-105065-C-S2026-10-12
00197157119836ZAVATION SCREW1011-O-105070-C-S2026-10-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157119638ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119645ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119652ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119669ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119676ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119683ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119690ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119706ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119713ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119720ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119737ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119744ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119751ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119775ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119782ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119799ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119805ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119812ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119829ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119836ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119843ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119850ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119867ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119874ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119881ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119898ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119904ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119911ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119928ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119935ZAVATION SCREWZavation LLCNKB2026-10-12