FDA.reportPublic FDA data

Zavation Deformity Polyaxial Screw

Primary DI
00197157042585
Brand
Zavation Deformity Polyaxial Screw
Company
Zavation LLC
Model
1011-C-9545-F
Device description
Fenestrated Cortical-Cancellous Threaded Screw 9.5 x 45
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
00197157042585PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197157042585001971570425851971570425850197157042585

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
00197157116712ZAVATION SCREW1011-O-075040-F-C2026-09-18
00197157116729ZAVATION SCREW1011-O-075045-F-C2026-09-18
00197157116736ZAVATION SCREW1011-O-075050-F-C2026-09-18
00197157116743ZAVATION SCREW1011-O-075055-F-C2026-09-18
00197157116750ZAVATION SCREW1011-O-075060-F-C2026-09-18
00197157116767ZAVATION SCREW1011-O-075065-F-C2026-09-18
00197157116774ZAVATION SCREW1011-O-075070-F-C2026-09-18
00197157116781ZAVATION SCREW1011-O-075075-F-C2026-09-18
00197157116798ZAVATION SCREW1011-O-075080-F-C2026-09-18
00197157116804ZAVATION SCREW1011-O-075085-F-C2026-09-18
00197157116811ZAVATION SCREW1011-O-075090-F-C2026-09-18
00197157116828ZAVATION SCREW1011-O-075095-F-C2026-09-18
00197157116835ZAVATION SCREW1011-O-075100-F-C2026-09-18
00197157116842ZAVATION SCREW1011-O-075105-F-C2026-09-18
00197157116859ZAVATION SCREW1011-O-075110-F-C2026-09-18
00197157116866ZAVATION SCREW1011-O-075025-F-S2026-09-18
00197157116873ZAVATION SCREW1011-O-075030-F-S2026-09-18
00197157116880ZAVATION SCREW1011-O-075035-F-S2026-09-18
00197157116897ZAVATION SCREW1011-O-075040-F-S2026-09-18
00197157116903ZAVATION SCREW1011-O-075045-F-S2026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000891428CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-09-20
00763000891480CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-09-20
00197157116712ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116729ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116736ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116743ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116750ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116767ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116774ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116781ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116798ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116804ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116811ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116828ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116835ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116842ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116859ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116866ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116873ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116880ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116897ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116903ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116910ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116927ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116934ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116941ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116958ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116965ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116972ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116989ZAVATION SCREWZavation LLCNKB2026-09-18