FDA.reportPublic FDA data

ZAVATION SCREW

Primary DI
00197157122577
Brand
ZAVATION SCREW
Company
Zavation LLC
Model
1010-C-065090-S-C
Device description
POLYAXIAL SCREW, CLOSED, TIGER 2 DEFORMITY, 6.5x90, SOLID, CORTICAL-CANCELLOUS THREAD
Published
2026-10-19
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
00197157122577PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197157122577001971571225771971571225770197157122577

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
00197157122515ZAVATION SCREW1010-C-065060-S-C2026-10-19
00197157122522ZAVATION SCREW1010-C-065065-S-C2026-10-19
00197157122539ZAVATION SCREW1010-C-065070-S-C2026-10-19
00197157122546ZAVATION SCREW1010-C-065075-S-C2026-10-19
00197157122553ZAVATION SCREW1010-C-065080-S-C2026-10-19
00197157122560ZAVATION SCREW1010-C-065085-S-C2026-10-19
00197157122584ZAVATION SCREW1010-C-065095-S-C2026-10-19
00197157122591ZAVATION SCREW1010-C-065100-S-C2026-10-19
00197157122607ZAVATION SCREW1010-C-065105-S-C2026-10-19
00197157122614ZAVATION SCREW1010-C-065110-S-C2026-10-19
00197157122621ZAVATION SCREW1010-C-065025-S-S2026-10-19
00197157122638ZAVATION SCREW1010-C-065030-S-S2026-10-19
00197157122645ZAVATION SCREW1010-C-065035-S-S2026-10-19
00197157122652ZAVATION SCREW1010-C-065040-S-S2026-10-19
00197157122669ZAVATION SCREW1010-C-065045-S-S2026-10-19
00197157122676ZAVATION SCREW1010-C-065050-S-S2026-10-19
00197157122683ZAVATION SCREW1010-C-065055-S-S2026-10-19
00197157122690ZAVATION SCREW1010-C-065060-S-S2026-10-19
00197157122706ZAVATION SCREW1010-C-065065-S-S2026-10-19
00197157122713ZAVATION SCREW1010-C-065070-S-S2026-10-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157122515ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122522ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122539ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122546ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122553ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122560ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122584ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122591ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122607ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122614ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122621ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122638ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122645ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122652ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122669ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122676ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122683ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122690ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122706ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122713ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122720ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122737ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122744ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122751ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122768ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122775ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122782ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122799ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122805ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122812ZAVATION SCREWZavation LLCNKB2026-10-19