FDA.reportPublic FDA data

ZAVATION Lateral CL5 PEEK NanoPrime Cage

Primary DI
00197157027964
Brand
ZAVATION Lateral CL5 PEEK NanoPrime Cage
Company
Zavation LLC
Model
NLL1855-0012
Device description
Lateral CL5 PEEK NanoPrime Cage - 18mm x 55mm x 12mm, 0°
Published
2025-07-09
Public version status
Update
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
OVVSorbent Hemoperfusion System For Use In The Treatment Of Hepatic Coma And Metabolic Disturbances

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVVSorbent Hemoperfusion System For Use In The Treatment Of Hepatic Coma And Metabolic Disturbances

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231743000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231743000F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate SystemCorelink, LLC2023-12-08MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00197157027964PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197157027964001971570279641971570279640197157027964

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation plate, non-bioabsorbableA small, implantable, non-customized sheet of solid material intended to be attached to the spine with screws for spinal immobilization; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).

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
00197157113384ZAVATION SCREW1011-O-045085-S-S2026-09-04
00197157113391ZAVATION SCREW1011-O-045090-S-S2026-09-04
00197157113407ZAVATION SCREW1011-O-045095-S-S2026-09-04
00197157113414ZAVATION SCREW1011-O-045100-S-S2026-09-04
00197157113421ZAVATION SCREW1011-O-045105-S-S2026-09-04
00197157113438ZAVATION SCREW1011-O-045110-S-S2026-09-04
00197157113445ZAVATION SCREW1011-O-045025-C-C2026-09-04
00197157113452ZAVATION SCREW1011-O-045030-C-C2026-09-04
00197157113469ZAVATION SCREW1011-O-045035-C-C2026-09-04
00197157113476ZAVATION SCREW1011-O-045040-C-C2026-09-04
00197157113483ZAVATION SCREW1011-O-045045-C-C2026-09-04
00197157113490ZAVATION SCREW1011-O-045050-C-C2026-09-04
00197157113506ZAVATION SCREW1011-O-045055-C-C2026-09-04
00197157113513ZAVATION SCREW1011-O-045060-C-C2026-09-04
00197157113520ZAVATION SCREW1011-O-045065-C-C2026-09-04
00197157113537ZAVATION SCREW1011-O-045070-C-C2026-09-04
00197157113544ZAVATION SCREW1011-O-045075-C-C2026-09-04
00197157113551ZAVATION SCREW1011-O-045080-C-C2026-09-04
00197157113568ZAVATION SCREW1011-O-045085-C-C2026-09-04
00197157113575ZAVATION SCREW1011-O-045090-C-C2026-09-04