FDA.reportPublic FDA data

Zavation Deformity Polyaxial Screw

Primary DI
00197157041588
Brand
Zavation Deformity Polyaxial Screw
Company
Zavation LLC
Model
1011-C-9585-S
Device description
Solid Cortical-Cancellous Threaded Screw 9.5 x 85
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
00197157041588PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197157041588001971570415881971570415880197157041588

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
00197157125325ZAVATION SCREW1010-C-085060-F-C2026-11-05
00197157125332ZAVATION SCREW1010-C-085065-F-C2026-11-05
00197157125349ZAVATION SCREW1010-C-085070-F-C2026-11-05
00197157125356ZAVATION SCREW1010-C-085075-F-C2026-11-05
00197157125363ZAVATION SCREW1010-C-085080-F-C2026-11-05
00197157125370ZAVATION SCREW1010-C-085085-F-C2026-11-05
00197157125387ZAVATION SCREW1010-C-085090-F-C2026-11-05
00197157125394ZAVATION SCREW1010-C-085095-F-C2026-11-05
00197157125400ZAVATION SCREW1010-C-085100-F-C2026-11-05
00197157125417ZAVATION SCREW1010-C-085105-F-C2026-11-05
00197157125424ZAVATION SCREW1010-C-085110-F-C2026-11-05
00197157125448ZAVATION SCREW1010-C-085030-F-S2026-11-05
00197157125455ZAVATION SCREW1010-C-085035-F-S2026-11-05
00197157125462ZAVATION SCREW1010-C-085040-F-S2026-11-05
00197157125479ZAVATION SCREW1010-C-085045-F-S2026-11-05
00197157125486ZAVATION SCREW1010-C-085050-F-S2026-11-05
00197157125493ZAVATION SCREW1010-C-085055-F-S2026-11-05
00197157125509ZAVATION SCREW1010-C-085075-F-S2026-11-05
00197157125516ZAVATION SCREW1010-C-085085-F-S2026-11-05
00197157125523ZAVATION SCREW1010-C-085095-F-S2026-11-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157125325ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125332ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125349ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125356ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125363ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125370ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125387ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125394ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125400ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125417ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125424ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125448ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125455ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125462ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125479ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125486ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125493ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125509ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125516ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125523ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125530ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125547ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125554ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125561ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125578ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125585ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125592ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125608ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125615ZAVATION SCREWZavation LLCNKB2026-11-05
00197157125622ZAVATION SCREWZavation LLCNKB2026-11-05