FDA.reportPublic FDA data

Zavation Deformity Polyaxial Screw

Primary DI
00197157041632
Brand
Zavation Deformity Polyaxial Screw
Company
Zavation LLC
Model
1011-C-95110-S
Device description
Solid Cortical-Cancellous Threaded Screw 9.5 x 110
Published
2024-10-22
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
00197157041632PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197157041632001971570416321971570416320197157041632

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
00842166187351Zavation821-2525042023-07-20
00842166187368Zavation821-2525082023-07-20
00842166187375Zavation821-5025042023-07-20
00842166187382Zavation821-5025082023-07-20
00842166187399Zavation821-1025042023-07-20
00842166187405Zavation821-1025082023-07-20
00842166186026Zavation810-0010252021-10-25
00842166186033Zavation810-0010502021-10-25
00842166186040Zavation810-0011002021-10-25
00842166188266Zavation805-00052021-02-05
00842166188273Zavation805-00102021-02-05
00842166188280Zavation805-00202021-02-05
00842166115484Zavation02-030-03-ZVG2019-02-01
00842166127951Zavation800-00022019-01-19
00842166127968Zavation800-00042019-01-19
00842166127975Zavation800-00102019-01-19
00842166127982Zavation801-00052019-01-19
00842166127999Zavation801-00102019-01-19
00842166128002Zavation801-00202019-01-19
00842166128019Zavation802-00052019-01-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157119355ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119362ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119379ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119386ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119393ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119409ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119416ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119423ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119430ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119447ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119454ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119461ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119478ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119485ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119492ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119508ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119515ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119522ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119539ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119546ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119553ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119560ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119577ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119584ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119591ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119607ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119614ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119621ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119089ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119096ZAVATION SCREWZavation LLCNKB2026-10-05