FDA.reportPublic FDA data

ZAVATION SCREW

Primary DI
00197157116811
Brand
ZAVATION SCREW
Company
Zavation LLC
Model
1011-O-075090-F-C
Device description
BIASED ANGLE POLYAXIAL SCREW, OPEN, TIGER 2 DEFORMITY, 7.5x90, FENESTRATED, CORTICAL-CANCELLOUS THREAD
Published
2026-09-18
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
00197157116811PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197157116811001971571168111971571168110197157116811

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
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
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
00197157116910ZAVATION SCREW1011-O-075050-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
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
00197157116996ZAVATION SCREWZavation LLCNKB2026-09-18