FDA.reportPublic FDA data

Zavation Deformity Polyaxial Screw

Primary DI
00197157030742
Brand
Zavation Deformity Polyaxial Screw
Company
Zavation LLC
Model
1010-C-85105-C
Device description
Cannulated Cortical-Cancellous Threaded Screw 8.5 x 105
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
00197157030742PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197157030742001971570307421971570307420197157030742

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
00197157124335ZAVATION SCREW1010-C-075070-F-C2026-11-03
00197157124342ZAVATION SCREW1010-C-075075-F-C2026-11-03
00197157124359ZAVATION SCREW1010-C-075080-F-C2026-11-03
00197157124366ZAVATION SCREW1010-C-075085-F-C2026-11-03
00197157124373ZAVATION SCREW1010-C-075090-F-C2026-11-03
00197157124380ZAVATION SCREW1010-C-075095-F-C2026-11-03
00197157124397ZAVATION SCREW1010-C-075100-F-C2026-11-03
00197157124403ZAVATION SCREW1010-C-075105-F-C2026-11-03
00197157124410ZAVATION SCREW1010-C-075110-F-C2026-11-03
00197157124427ZAVATION SCREW1010-C-075025-F-S2026-11-03
00197157124434ZAVATION SCREW1010-C-075030-F-S2026-11-03
00197157124441ZAVATION SCREW1010-C-075035-F-S2026-11-03
00197157124458ZAVATION SCREW1010-C-075040-F-S2026-11-03
00197157124465ZAVATION SCREW1010-C-075045-F-S2026-11-03
00197157124472ZAVATION SCREW1010-C-075050-F-S2026-11-03
00197157124489ZAVATION SCREW1010-C-075055-F-S2026-11-03
00197157124496ZAVATION SCREW1010-C-075075-F-S2026-11-03
00197157124502ZAVATION SCREW1010-C-075085-F-S2026-11-03
00197157124519ZAVATION SCREW1010-C-075095-F-S2026-11-03
00197157124526ZAVATION SCREW1010-C-075105-F-S2026-11-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157124618ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124625ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124632ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124649ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124656ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124663ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124670ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124687ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124694ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124700ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124717ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124724ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124731ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124748ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124755ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124762ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124779ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124786ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124793ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124809ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124816ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124823ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124830ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124847ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124854ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124861ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124878ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124885ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124892ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124908ZAVATION SCREWZavation LLCNKB2026-11-04