FDA.reportPublic FDA data

Zavation Deformity Polyaxial Screw

Primary DI
00197157042462
Brand
Zavation Deformity Polyaxial Screw
Company
Zavation LLC
Model
1011-C-8575-F
Device description
Fenestrated Cortical-Cancellous Threaded Screw 8.5 x 75
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
00197157042462PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197157042462001971570424621971570424620197157042462

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
00197157123673ZAVATION SCREW1010-C-075100-S-C2026-11-02
00197157123680ZAVATION SCREW1010-C-075105-S-C2026-11-02
00197157123697ZAVATION SCREW1010-C-075110-S-C2026-11-02
00197157123703ZAVATION SCREW1010-C-075025-S-S2026-11-02
00197157123710ZAVATION SCREW1010-C-075030-S-S2026-11-02
00197157123727ZAVATION SCREW1010-C-075035-S-S2026-11-02
00197157123734ZAVATION SCREW1010-C-075040-S-S2026-11-02
00197157123741ZAVATION SCREW1010-C-075045-S-S2026-11-02
00197157123758ZAVATION SCREW1010-C-075050-S-S2026-11-02
00197157123765ZAVATION SCREW1010-C-075055-S-S2026-11-02
00197157123772ZAVATION SCREW1010-C-075060-S-S2026-11-02
00197157123789ZAVATION SCREW1010-C-075065-S-S2026-11-02
00197157123796ZAVATION SCREW1010-C-075070-S-S2026-11-02
00197157123802ZAVATION SCREW1010-C-075075-S-S2026-11-02
00197157123819ZAVATION SCREW1010-C-075080-S-S2026-11-02
00197157123826ZAVATION SCREW1010-C-075085-S-S2026-11-02
00197157123833ZAVATION SCREW1010-C-075090-S-S2026-11-02
00197157123840ZAVATION SCREW1010-C-075095-S-S2026-11-02
00197157123857ZAVATION SCREW1010-C-075100-S-S2026-11-02
00197157123864ZAVATION SCREW1010-C-075105-S-S2026-11-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157123673ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123680ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123697ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123703ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123710ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123727ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123734ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123741ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123758ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123765ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123772ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123789ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123796ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123802ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123819ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123826ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123833ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123840ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123857ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123864ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123871ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123888ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123895ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123901ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123918ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123925ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123932ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123949ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123956ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123963ZAVATION SCREWZavation LLCNKB2026-11-02