FDA.reportPublic FDA data

ZAVATION SCREW

Primary DI
00197157117306
Brand
ZAVATION SCREW
Company
Zavation LLC
Model
1011-O-085065-S-S
Device description
BIASED ANGLE POLYAXIAL SCREW, OPEN, TIGER 2 DEFORMITY, 8.5x65, SOLID, STANDARD THREAD
Published
2026-09-21
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
00197157117306PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197157117306001971571173061971571173060197157117306

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.

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
00197157117214ZAVATION SCREW1011-O-085110-S-C2026-09-21
00197157117221ZAVATION SCREW1011-O-085025-S-S2026-09-21
00197157117238ZAVATION SCREW1011-O-085030-S-S2026-09-21
00197157117245ZAVATION SCREW1011-O-085035-S-S2026-09-21
00197157117252ZAVATION SCREW1011-O-085040-S-S2026-09-21
00197157117269ZAVATION SCREW1011-O-085045-S-S2026-09-21
00197157117276ZAVATION SCREW1011-O-085050-S-S2026-09-21
00197157117283ZAVATION SCREW1011-O-085055-S-S2026-09-21
00197157117290ZAVATION SCREW1011-O-085060-S-S2026-09-21
00197157117313ZAVATION SCREW1011-O-085070-S-S2026-09-21
00197157117320ZAVATION SCREW1011-O-085075-S-S2026-09-21
00197157117337ZAVATION SCREW1011-O-085080-S-S2026-09-21
00197157117344ZAVATION SCREW1011-O-085085-S-S2026-09-21
00197157117351ZAVATION SCREW1011-O-085090-S-S2026-09-21
00197157117368ZAVATION SCREW1011-O-085095-S-S2026-09-21
00197157117375ZAVATION SCREW1011-O-085100-S-S2026-09-21
00197157117382ZAVATION SCREW1011-O-085105-S-S2026-09-21
00197157117399ZAVATION SCREW1011-O-085110-S-S2026-09-21
00197157117405ZAVATION SCREW1011-O-085025-C-C2026-09-21
00197157117412ZAVATION SCREW1011-O-085030-C-C2026-09-21

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00613994568823TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2015-08-05
00613994888143TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2015-08-05
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