FDA.reportPublic FDA data

ZAVATION ROD

Primary DI
00197157059279
Brand
ZAVATION ROD
Company
Zavation LLC
Model
R5507-170
Device description
5527 SERIES STRAIGHT ROD MIS
Published
2026-06-02
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
00197157059279PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197157059279001971570592791971570592790197157059279

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
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
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
00197157059286ZAVATION RODZavation LLCNKB2026-06-02