FDA.reportPublic FDA data

Zavation

Primary DI
00842166185241
Brand
Zavation
Company
Zavation LLC
Model
410-1058-50
Device description
Drill 5.0
Published
2019-12-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWQAppliance, Fixation, Spinal Intervertebral Body
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190317000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190317000Zavation Spinal SystemZavation Medical Products, LLC2019-04-11NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842166185241PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842166185241008421661852418421661852410842166185241

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, non-sterileA small, non-sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Screws available are: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression. This device must be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
601-919-1119info@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
00197157119089ZAVATION SCREW1011-O-095055-F-S2026-10-05
00197157119096ZAVATION SCREW1011-O-095060-F-S2026-10-05
00197157119102ZAVATION SCREW1011-O-095065-F-S2026-10-05
00197157119119ZAVATION SCREW1011-O-095070-F-S2026-10-05
00197157119126ZAVATION SCREW1011-O-095075-F-S2026-10-05
00197157119133ZAVATION SCREW1011-O-095080-F-S2026-10-05
00197157119140ZAVATION SCREW1011-O-095085-F-S2026-10-05
00197157119157ZAVATION SCREW1011-O-095090-F-S2026-10-05
00197157119164ZAVATION SCREW1011-O-095095-F-S2026-10-05
00197157119171ZAVATION SCREW1011-O-095100-F-S2026-10-05
00197157119188ZAVATION SCREW1011-O-095105-F-S2026-10-05
00197157119195ZAVATION SCREW1011-O-095110-F-S2026-10-05
00197157119201ZAVATION SCREW1011-O-105025-S-C2026-10-05
00197157119218ZAVATION SCREW1011-O-105030-S-C2026-10-05
00197157119225ZAVATION SCREW1011-O-105035-S-C2026-10-05
00197157119232ZAVATION SCREW1011-O-105040-S-C2026-10-05
00197157119249ZAVATION SCREW1011-O-105045-S-C2026-10-05
00197157119256ZAVATION SCREW1011-O-105050-S-C2026-10-05
00197157119263ZAVATION SCREW1011-O-105055-S-C2026-10-05
00197157119270ZAVATION SCREW1011-O-105060-S-C2026-10-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157119089ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119096ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119102ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119119ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119126ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119133ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119140ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119157ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119164ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119171ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119188ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119195ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119201ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119218ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119225ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119232ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119249ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119256ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119263ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119270ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119287ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119294ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119300ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119317ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119324ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119331ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119348ZAVATION SCREWZavation LLCNKB2026-10-05
00810228161687corraCarlsmed, Inc.KWQ2026-10-05
00810228161694corraCarlsmed, Inc.KWQ2026-10-05
00810228161700corraCarlsmed, Inc.KWQ2026-10-05