FDA.reportPublic FDA data

Zavation Z-Span Lumbar Awl

Primary DI
00197157049584
Brand
Zavation Z-Span Lumbar Awl
Company
Zavation LLC
Model
198-1033
Device description
Z-Span Lumbar Awl – Inline, 20mm
Published
2024-12-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWPAppliance, Fixation, Spinal Interlaminal
NKGPosterior Cervical Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
NKGPosterior Cervical Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160362000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160362000Z-Span Plate SystemZavation, LLC2016-03-22KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00197157049584PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197157049584001971570495841971570495840197157049584

GMDN Terms#

Term, Definition table
TermDefinition
Bone awl, reusableA spike-like, manual, orthopaedic surgical instrument intended to bore holes in bone. It is a straight or slightly curve rod-like instrument with a sharp, trocar-like point at the distal end and a T-shaped handle at the proximal end, typically made of metallic and/or synthetic material. 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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888857037953EVEREST® Spinal SystemVB Spine LLCKWP2026-06-11
10888857037977EVEREST® Spinal SystemVB Spine LLCKWP2026-06-11
10888857001428DENALI® MI Spinal SystemVB Spine LLCKWP2018-11-05
10888857001435DENALI® MI Spinal SystemVB Spine LLCKWP2018-11-05
10888857001459DENALI® MI Spinal SystemVB Spine LLCKWP2018-11-05
10888857001657DENALI® MI Spinal SystemVB Spine LLCKWP2018-11-05
10888857001688DENALI® MI Spinal SystemVB Spine LLCKWP2018-11-05
10888857001695DENALI® MI Spinal SystemVB Spine LLCKWP2018-11-05
10888857001701DENALI® MI Spinal SystemVB Spine LLCKWP2018-11-05
10888857001718DENALI® MI Spinal SystemVB Spine LLCKWP2018-11-05
10888857046733MESA® Small Stature Spinal SystemVB Spine LLCKWP2016-09-02
10888857008724EVEREST® Spinal SystemVB Spine LLCKWP2016-03-10
10888857001497DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001527DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001589DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001619DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001640DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001725DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001763DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001787DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001824DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001848DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001923DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001947DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001978DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001992DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857002036DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857002050DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857002074DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857002098DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24