FDA.reportPublic FDA data

Zavation Deformity Polyaxial Screw

Primary DI
00197157030919
Brand
Zavation Deformity Polyaxial Screw
Company
Zavation LLC
Model
1010-C-95100-C
Device description
Cannulated Cortical-Cancellous Threaded Screw 9.5 x 100
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
00197157030919PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197157030919001971570309191971570309190197157030919

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
00197157119089ZAVATION SCREW1011-O-095055-F-S2026-10-05
00197157119096ZAVATION SCREW1011-O-095060-F-S2026-10-05
00197157119102ZAVATION SCREW1011-O-095065-F-S2026-10-05
00197157119119ZAVATION SCREW1011-O-095070-F-S2026-10-05
00197157119126ZAVATION SCREW1011-O-095075-F-S2026-10-05
00197157119133ZAVATION SCREW1011-O-095080-F-S2026-10-05
00197157119140ZAVATION SCREW1011-O-095085-F-S2026-10-05
00197157119157ZAVATION SCREW1011-O-095090-F-S2026-10-05
00197157119164ZAVATION SCREW1011-O-095095-F-S2026-10-05
00197157119171ZAVATION SCREW1011-O-095100-F-S2026-10-05
00197157119188ZAVATION SCREW1011-O-095105-F-S2026-10-05
00197157119195ZAVATION SCREW1011-O-095110-F-S2026-10-05
00197157119201ZAVATION SCREW1011-O-105025-S-C2026-10-05
00197157119218ZAVATION SCREW1011-O-105030-S-C2026-10-05
00197157119225ZAVATION SCREW1011-O-105035-S-C2026-10-05
00197157119232ZAVATION SCREW1011-O-105040-S-C2026-10-05
00197157119249ZAVATION SCREW1011-O-105045-S-C2026-10-05
00197157119256ZAVATION SCREW1011-O-105050-S-C2026-10-05
00197157119263ZAVATION SCREW1011-O-105055-S-C2026-10-05
00197157119270ZAVATION SCREW1011-O-105060-S-C2026-10-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157119089ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119096ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119102ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119119ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119126ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119133ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119140ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119157ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119164ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119171ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119188ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119195ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119201ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119218ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119225ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119232ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119249ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119256ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119263ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119270ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119287ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119294ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119300ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119317ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119324ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119331ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119348ZAVATION SCREWZavation LLCNKB2026-10-05
00197157118280ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118297ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118303ZAVATION SCREWZavation LLCNKB2026-10-01