FDA.reportPublic FDA data

ZAVATION ROD

Primary DI
00197157079703
Brand
ZAVATION ROD
Company
Zavation LLC
Model
380-MS085
Device description
STRAIGHT HEX ROD, 5.5x85
Published
2026-05-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KQPFluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase
KWQAppliance, Fixation, Spinal Intervertebral Body
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KQPFluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl TransferaseClinical Chemistry2
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2
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
00197157079703PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197157079703001971570797031971570797030197157079703

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone pin, non-bioabsorbableA thin, implantable rod intended to be used for the stabilization of a bone fracture or bone grafts, or for an osteotomy or arthrodesis (internal and/or external fixation). It is typically drilled into bone and may be smooth or threaded, solid or cannulated, and/or semi-flexible. Also known as a Kirschner-wire (K-wire), it may in addition be intended to assist with the introduction of a surgical instrument and/or implant; it is not intended for implantation into the intramedullary canal (i.e., not a nail). It is made of a non-bioabsorbable material (e.g., stainless steel). Some designs may have a break-off shank and/or be coated to improve long-term fixation. This is a single-use 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
00197157058982ZAVATION INSTRUMENT TRAY1010-90002026-06-02
00197157058999ZAVATION INSTRUMENT TRAY1010-9000-12026-06-02
00197157059002ZAVATION INSTRUMENT TRAY1010-9000-22026-06-02
00197157059019ZAVATION INSTRUMENT TRAY1010-90012026-06-02
00197157059026ZAVATION INSTRUMENT TRAY1010-9001-12026-06-02
00197157059033ZAVATION INSTRUMENT TRAY1010-9001-22026-06-02
00197157059040ZAVATION INSTRUMENT TRAY1010-9001-32026-06-02
00197157059057ZAVATION CADDY1010-9003-32026-06-02
00197157059064ZAVATION CADDY1010-9003-42026-06-02
00197157059071ZAVATION RODR5507-0352026-06-02
00197157059088ZAVATION RODR5507-0402026-06-02
00197157059095ZAVATION RODR5507-0452026-06-02
00197157059101ZAVATION RODR5507-0502026-06-02
00197157059118ZAVATION RODR5507-0552026-06-02
00197157059125ZAVATION RODR5507-0602026-06-02
00197157059132ZAVATION RODR5507-0652026-06-02
00197157059149ZAVATION RODR5507-0702026-06-02
00197157059156ZAVATION RODR5507-0752026-06-02
00197157059163ZAVATION RODR5507-0802026-06-02
00197157059170ZAVATION RODR5507-0852026-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157058982ZAVATION INSTRUMENT TRAYZavation LLCNKB2026-06-02
00197157058999ZAVATION INSTRUMENT TRAYZavation LLCNKB2026-06-02
00197157059002ZAVATION INSTRUMENT TRAYZavation LLCNKB2026-06-02
00197157059019ZAVATION INSTRUMENT TRAYZavation LLCNKB2026-06-02
00197157059026ZAVATION INSTRUMENT TRAYZavation LLCNKB2026-06-02
00197157059033ZAVATION INSTRUMENT TRAYZavation LLCNKB2026-06-02
00197157059040ZAVATION INSTRUMENT TRAYZavation LLCNKB2026-06-02
00197157059057ZAVATION CADDYZavation LLCNKB2026-06-02
00197157059064ZAVATION CADDYZavation LLCNKB2026-06-02
00197157059071ZAVATION RODZavation LLCNKB2026-06-02
00197157059088ZAVATION RODZavation LLCNKB2026-06-02
00197157059095ZAVATION RODZavation LLCNKB2026-06-02
00197157059101ZAVATION RODZavation LLCNKB2026-06-02
00197157059118ZAVATION RODZavation LLCNKB2026-06-02
00197157059125ZAVATION RODZavation LLCNKB2026-06-02
00197157059132ZAVATION RODZavation LLCNKB2026-06-02
00197157059149ZAVATION RODZavation LLCNKB2026-06-02
00197157059156ZAVATION RODZavation LLCNKB2026-06-02
00197157059163ZAVATION RODZavation LLCNKB2026-06-02
00197157059170ZAVATION RODZavation LLCNKB2026-06-02
00197157059187ZAVATION RODZavation LLCNKB2026-06-02
00197157059194ZAVATION RODZavation LLCNKB2026-06-02
00197157059200ZAVATION RODZavation LLCNKB2026-06-02
00197157059217ZAVATION RODZavation LLCNKB2026-06-02
00197157059224ZAVATION RODZavation LLCNKB2026-06-02
00197157059231ZAVATION RODZavation LLCNKB2026-06-02
00197157059248ZAVATION RODZavation LLCNKB2026-06-02
00197157059255ZAVATION RODZavation LLCNKB2026-06-02
00197157059262ZAVATION RODZavation LLCNKB2026-06-02
00197157059279ZAVATION RODZavation LLCNKB2026-06-02