FDA.reportPublic FDA data

Jazz Spinal System

Primary DI
03607506344613
Brand
Jazz Spinal System
Company
IMPLANET
Model
634461
Device description
MIS Pre-bent Rod 5.5x65
Published
2026-04-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
K240392000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240392000JAZZ Spinal SystemImplanet2024-05-06NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03607506344613PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03607506344613036075063446133607506344613

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system rodAn implantable component of a bone-screw internal spinal fixation system in the form of a thin cylinder intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is designed as a longitudinal (intervertebral) connecting element passing through the system’s implantable screw heads or hooks. It is available in various forms (e.g., straight, curved, rigid, flexible, with varying diameters); flexible types may allow small movements of the spine.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
291993439
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03607505700755Jazz Spinal System5700755700752026-04-02
03607506310632Jazz Spinal System6310636310632026-04-02
03607506310656Jazz Spinal System6310656310652026-04-02
03607506310663Jazz Spinal System6310666310662026-04-02
03607506310779Jazz Spinal System6310776310772026-04-02
03607506313473Jazz Spinal System6313476313472026-04-02
03607506313527Jazz Spinal System6313526313522026-04-02
03607506317020Jazz Spinal System6317026317022026-04-02
03607506335932Jazz Spinal System6335932026-04-02
03607506340417Jazz Spinal System6340412026-04-02
03607506343623Jazz Spinal System6343622026-04-02
03607506343784Jazz Spinal System6343782026-04-02
03607506344569Jazz Spinal System6344562026-04-02
03607506344576Jazz Spinal System6344572026-04-02
03607506344583Jazz Spinal System6344582026-04-02
03607506344620Jazz Spinal System6344622026-04-02
03607505700830Jazz Spinal System5700835700832025-11-28
03607506348512Jazz Spinal System6348512025-11-18
03607506348529Jazz Spinal System6348522025-11-18
03607506310496Jazz Spinal System6310496310492025-10-28

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07613153045755XIA IStryker CorporationNKB2014-12-08
07613153045762XIA IIStryker CorporationNKB2014-12-08
07613153045847XIA IIStryker CorporationNKB2014-12-08
07613153045854XIA IIStryker CorporationNKB2014-12-08
07613153045861XIA IIStryker CorporationNKB2014-12-08
07613153045885XIA IIStryker CorporationNKB2014-12-08
07613153045892XIA IIStryker CorporationNKB2014-12-08
07613153045908XIA IIStryker CorporationNKB2014-12-08
07613153045915XIA IIStryker CorporationNKB2014-12-08
07613153045922XIA IIStryker CorporationNKB2014-12-08
07613153045960XIA IIStryker CorporationNKB2014-12-08
07613153046011XIA STAINLESS STEELStryker CorporationNKB2014-12-08
07613153046028XIA STAINLESS STEELStryker CorporationNKB2014-12-08
07613153046035XIA STAINLESS STEELStryker CorporationNKB2014-12-08
07613153046059XIA STAINLESS STEELStryker CorporationNKB2014-12-08
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07613153046141XIA STAINLESS STEELStryker CorporationNKB2014-12-08
07613153046165XIA STAINLESS STEELStryker CorporationNKB2014-12-08
07613153046172XIA STAINLESS STEELStryker CorporationNKB2014-12-08
07613153140344XIA IIStryker CorporationNKB2014-12-08
07613153140351XIA IIStryker CorporationNKB2014-12-08
07613153140368XIA IIStryker CorporationNKB2014-12-08
07613153140382XIA IIStryker CorporationNKB2014-12-08
07613153143512XIA STAINLESS STEELStryker CorporationNKB2014-12-08