FDA.reportPublic FDA data

ZAVATION ROD BENDER

Primary DI
00197157071400
Brand
ZAVATION ROD BENDER
Company
Zavation LLC
Model
989-1065-R
Device description
INSITU BENDER - RIGHT 6.0 ROD
Published
2025-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00197157071400PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197157071400001971570714001971570714000197157071400

GMDN Terms#

Term, Definition table
TermDefinition
Manual orthopaedic bender, reusableA manually-operated surgical instrument designed to bend orthopaedic devices, typically those for implantation (e.g., orthopaedic rods, bone fixation plates), to an appropriate anatomical shape. The bending process is typically performed within the operating room (OR), inside or outside of the operative sterile field. The device may be hand held or table mounted. This is a reusable device.

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
Lot or batch
true
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
00197157118280ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118297ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118303ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118310ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118327ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118334ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118341ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118358ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118365ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118372ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118389ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118396ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118402ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118419ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118426ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118433ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118440ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118457ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118464ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118471ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118488ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118495ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118501ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118518ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118525ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118532ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118549ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118556ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118563ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118570ZAVATION SCREWZavation LLCNKB2026-10-01