FDA.reportPublic FDA data

ZAVATION SCREW

Primary DI
00197157119133
Brand
ZAVATION SCREW
Company
Zavation LLC
Model
1011-O-095080-F-S
Device description
BIASED ANGLE POLYAXIAL SCREW, OPEN, TIGER 2 DEFORMITY, 9.5x80, FENESTRATED, STANDARD THREAD
Published
2026-10-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
K243908000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243908000Tiger 2 SystemZavation Medical Products, LLC2025-02-03NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00197157119133PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197157119133001971571191331971571191330197157119133

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable, implantable rod intended 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, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00197157119089ZAVATION SCREW1011-O-095055-F-S2026-10-05
00197157119096ZAVATION SCREW1011-O-095060-F-S2026-10-05
00197157119102ZAVATION SCREW1011-O-095065-F-S2026-10-05
00197157119119ZAVATION SCREW1011-O-095070-F-S2026-10-05
00197157119126ZAVATION SCREW1011-O-095075-F-S2026-10-05
00197157119140ZAVATION SCREW1011-O-095085-F-S2026-10-05
00197157119157ZAVATION SCREW1011-O-095090-F-S2026-10-05
00197157119164ZAVATION SCREW1011-O-095095-F-S2026-10-05
00197157119171ZAVATION SCREW1011-O-095100-F-S2026-10-05
00197157119188ZAVATION SCREW1011-O-095105-F-S2026-10-05
00197157119195ZAVATION SCREW1011-O-095110-F-S2026-10-05
00197157119201ZAVATION SCREW1011-O-105025-S-C2026-10-05
00197157119218ZAVATION SCREW1011-O-105030-S-C2026-10-05
00197157119225ZAVATION SCREW1011-O-105035-S-C2026-10-05
00197157119232ZAVATION SCREW1011-O-105040-S-C2026-10-05
00197157119249ZAVATION SCREW1011-O-105045-S-C2026-10-05
00197157119256ZAVATION SCREW1011-O-105050-S-C2026-10-05
00197157119263ZAVATION SCREW1011-O-105055-S-C2026-10-05
00197157119270ZAVATION SCREW1011-O-105060-S-C2026-10-05
00197157119287ZAVATION SCREW1011-O-105065-S-C2026-10-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157119089ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119096ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119102ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119119ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119126ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119140ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119157ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119164ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119171ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119188ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119195ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119201ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119218ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119225ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119232ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119249ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119256ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119263ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119270ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119287ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119294ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119300ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119317ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119324ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119331ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119348ZAVATION SCREWZavation LLCNKB2026-10-05
00197157118280ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118297ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118303ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118310ZAVATION SCREWZavation LLCNKB2026-10-01