FDA.reportPublic FDA data

ZAVATION SCREW

Primary DI
00197157081522
Brand
ZAVATION SCREW
Company
Zavation LLC
Model
35035-12
Device description
3500 SERIES POLYAXIAL SCREW, 3.5MM X 12MM
Published
2026-06-04
Public version status
Update
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00197157081522PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197157081522001971570815221971570815220197157081522

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
M711620155550Vector™ Pedicle Screw SystemINNO Holdings, Inc.KWP2026-09-30
M711620155600Vector™ Pedicle Screw SystemINNO Holdings, Inc.KWP2026-09-30
M711620155650Vector™ Pedicle Screw SystemINNO Holdings, Inc.KWP2026-09-30
M711620155700Vector™ Pedicle Screw SystemINNO Holdings, Inc.KWP2026-09-30
M711620155750Vector™ Pedicle Screw SystemINNO Holdings, Inc.KWP2026-09-30
M711620155800Vector™ Pedicle Screw SystemINNO Holdings, Inc.KWP2026-09-30
M711620155850Vector™ Pedicle Screw SystemINNO Holdings, Inc.KWP2026-09-30
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10888857598447Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
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10888857598478Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24