FDA.reportPublic FDA data

ZAVATION SCREW

Primary DI
00197157081515
Brand
ZAVATION SCREW
Company
Zavation LLC
Model
35035-10
Device description
3500 SERIES POLYAXIAL SCREW, 3.5MM X 10MM
Published
2026-06-04
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
KWPAppliance, Fixation, Spinal Interlaminal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132504000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132504000TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEMCorelink, LLC2013-11-25KWP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00197157081515PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197157081515001971570815151971570815150197157081515

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
00197157059521ZAVATION RODR5522-0852026-06-04
00197157059538ZAVATION RODR5522-0902026-06-04
00197157059545ZAVATION RODR5522-0952026-06-04
00197157059552ZAVATION RODR5522-1002026-06-04
00197157059569ZAVATION RODR5522-1052026-06-04
00197157059576ZAVATION RODR5522-1102026-06-04
00197157059583ZAVATION RODR5522-1152026-06-04
00197157059590ZAVATION RODR5522-1202026-06-04
00197157059606ZAVATION RODR5522-1252026-06-04
00197157059613ZAVATION RODR5522-1302026-06-04
00197157059620ZAVATION RODR5522-1352026-06-04
00197157059637ZAVATION RODR5522-1402026-06-04
00197157059644ZAVATION RODR5522-1452026-06-04
00197157059651ZAVATION RODR5522-1502026-06-04
00197157059668ZAVATION RODR5522-1602026-06-04
00197157081522ZAVATION SCREW35035-122026-06-04
00197157081539ZAVATION SCREW35035-142026-06-04
00197157081546ZAVATION SCREW35035-162026-06-04
00197157081553ZAVATION SCREW35035-182026-06-04
00197157081560ZAVATION SCREW35035-202026-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157081522ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081539ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081546ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081553ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081560ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081577ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081584ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081591ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081607ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081614ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081621ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081638ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081645ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081652ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081669ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081676ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081683ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081690ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081706ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081713ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081720ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081737ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081744ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081751ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081768ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081775ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081782ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081799ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081805ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081812ZAVATION SCREWZavation LLCKWP2026-06-04