FDA.reportPublic FDA data

Zavation Deformity Polyaxial Screw

Primary DI
00197157030957
Brand
Zavation Deformity Polyaxial Screw
Company
Zavation LLC
Model
1010-C-10530-C
Device description
Cannulated Cortical-Cancellous Threaded Screw 10.5 x 30
Published
2024-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K222614000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222614000Zavation Spinal SystemZavation Medical Products, LLC2022-12-05NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00197157030957PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197157030957001971570309571971570309570197157030957

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable, implantable rod intended to be used 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, or used in dentistry/orthodontics, craniofacial or spinal bones. It is typically of cortical or cancellous design and has a drive (e.g., a slot, or of cross, star, or polygonal shape) at its proximal end for introduction with a screwdriver. It is made of non-bioabsorbable materials (e.g., metal).

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
Lot or batch
true
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
00197157119768ZAVATION SCREW1011-O-105035-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

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
00197157119768ZAVATION 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