FDA.reportPublic FDA data

ZAVATION SCREW

Primary DI
00197157119430
Brand
ZAVATION SCREW
Company
Zavation LLC
Model
1011-O-105050-S-S
Device description
BIASED ANGLE POLYAXIAL SCREW, OPEN, TIGER 2 DEFORMITY, 10.5x50, SOLID, STANDARD THREAD
Published
2026-10-07
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
00197157119430PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197157119430001971571194301971571194300197157119430

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
00842166187351Zavation821-2525042023-07-20
00842166187368Zavation821-2525082023-07-20
00842166187375Zavation821-5025042023-07-20
00842166187382Zavation821-5025082023-07-20
00842166187399Zavation821-1025042023-07-20
00842166187405Zavation821-1025082023-07-20
00842166186026Zavation810-0010252021-10-25
00842166186033Zavation810-0010502021-10-25
00842166186040Zavation810-0011002021-10-25
00842166188266Zavation805-00052021-02-05
00842166188273Zavation805-00102021-02-05
00842166188280Zavation805-00202021-02-05
00842166115484Zavation02-030-03-ZVG2019-02-01
00842166127951Zavation800-00022019-01-19
00842166127968Zavation800-00042019-01-19
00842166127975Zavation800-00102019-01-19
00842166127982Zavation801-00052019-01-19
00842166127999Zavation801-00102019-01-19
00842166128002Zavation801-00202019-01-19
00842166128019Zavation802-00052019-01-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157119355ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119362ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119379ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119386ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119393ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119409ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119416ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119423ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119447ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119454ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119461ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119478ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119485ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119492ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119508ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119515ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119522ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119539ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119546ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119553ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119560ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119577ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119584ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119591ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119607ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119614ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119621ZAVATION SCREWZavation LLCNKB2026-10-07
00197157119089ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119096ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119102ZAVATION SCREWZavation LLCNKB2026-10-05