FDA.reportPublic FDA data

ZAVATION SCREW

Primary DI
00197157123970
Brand
ZAVATION SCREW
Company
Zavation LLC
Model
1010-C-075070-C-C
Device description
POLYAXIAL SCREW, CLOSED, TIGER 2 DEFORMITY, 7.5x70, CANNULATED, CORTICAL-CANCELLOUS THREAD
Published
2026-11-02
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
00197157123970PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197157123970001971571239701971571239700197157123970

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
00197157123673ZAVATION SCREW1010-C-075100-S-C2026-11-02
00197157123680ZAVATION SCREW1010-C-075105-S-C2026-11-02
00197157123697ZAVATION SCREW1010-C-075110-S-C2026-11-02
00197157123703ZAVATION SCREW1010-C-075025-S-S2026-11-02
00197157123710ZAVATION SCREW1010-C-075030-S-S2026-11-02
00197157123727ZAVATION SCREW1010-C-075035-S-S2026-11-02
00197157123734ZAVATION SCREW1010-C-075040-S-S2026-11-02
00197157123741ZAVATION SCREW1010-C-075045-S-S2026-11-02
00197157123758ZAVATION SCREW1010-C-075050-S-S2026-11-02
00197157123765ZAVATION SCREW1010-C-075055-S-S2026-11-02
00197157123772ZAVATION SCREW1010-C-075060-S-S2026-11-02
00197157123789ZAVATION SCREW1010-C-075065-S-S2026-11-02
00197157123796ZAVATION SCREW1010-C-075070-S-S2026-11-02
00197157123802ZAVATION SCREW1010-C-075075-S-S2026-11-02
00197157123819ZAVATION SCREW1010-C-075080-S-S2026-11-02
00197157123826ZAVATION SCREW1010-C-075085-S-S2026-11-02
00197157123833ZAVATION SCREW1010-C-075090-S-S2026-11-02
00197157123840ZAVATION SCREW1010-C-075095-S-S2026-11-02
00197157123857ZAVATION SCREW1010-C-075100-S-S2026-11-02
00197157123864ZAVATION SCREW1010-C-075105-S-S2026-11-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157123673ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123680ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123697ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123703ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123710ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123727ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123734ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123741ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123758ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123765ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123772ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123789ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123796ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123802ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123819ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123826ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123833ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123840ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123857ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123864ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123871ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123888ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123895ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123901ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123918ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123925ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123932ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123949ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123956ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123963ZAVATION SCREWZavation LLCNKB2026-11-02