FDA.reportPublic FDA data

ZAVATION SCREW

Primary DI
00197157117665
Brand
ZAVATION SCREW
Company
Zavation LLC
Model
1011-O-085065-C-S
Device description
BIASED ANGLE POLYAXIAL SCREW, OPEN, TIGER 2 DEFORMITY, 8.5x65, CANNULATED, STANDARD THREAD
Published
2026-09-28
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
NBKSystem, Test, (Ihc), Tumor Marker, Monitoring, Bladder Cancer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBKSystem, Test, (Ihc), Tumor Marker, Monitoring, Bladder CancerHematology2

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
00197157117665PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197157117665001971571176651971571176650197157117665

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
00197157118280ZAVATION SCREW1011-O-095105-S-C2026-10-01
00197157118297ZAVATION SCREW1011-O-095110-S-C2026-10-01
00197157118303ZAVATION SCREW1011-O-095025-S-S2026-10-01
00197157118310ZAVATION SCREW1011-O-095030-S-S2026-10-01
00197157118327ZAVATION SCREW1011-O-095035-S-S2026-10-01
00197157118334ZAVATION SCREW1011-O-095040-S-S2026-10-01
00197157118341ZAVATION SCREW1011-O-095045-S-S2026-10-01
00197157118358ZAVATION SCREW1011-O-095050-S-S2026-10-01
00197157118365ZAVATION SCREW1011-O-095055-S-S2026-10-01
00197157118372ZAVATION SCREW1011-O-095060-S-S2026-10-01
00197157118389ZAVATION SCREW1011-O-095065-S-S2026-10-01
00197157118396ZAVATION SCREW1011-O-095070-S-S2026-10-01
00197157118402ZAVATION SCREW1011-O-095075-S-S2026-10-01
00197157118419ZAVATION SCREW1011-O-095080-S-S2026-10-01
00197157118426ZAVATION SCREW1011-O-095085-S-S2026-10-01
00197157118433ZAVATION SCREW1011-O-095090-S-S2026-10-01
00197157118440ZAVATION SCREW1011-O-095095-S-S2026-10-01
00197157118457ZAVATION SCREW1011-O-095100-S-S2026-10-01
00197157118464ZAVATION SCREW1011-O-095105-S-S2026-10-01
00197157118471ZAVATION SCREW1011-O-095110-S-S2026-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810088653155Goblin Pedicle Screw SystemMEDYNUS, INC.NBK2021-10-07
00840019935357Reform TiPRECISION SPINE, INC.NBK2019-10-07
08806162165852AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162165869AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162165876AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162165883AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162165890AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162165906AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162165913AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162165920AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162165937AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162165944AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162165951AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162165968AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162165975AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162165982AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162165999AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162166002AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162166019AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162166026AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162166262AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162166279AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162166286AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162166293AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162166309AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162166316AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162166323AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162166330AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162166347AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162166354AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07