FDA.reportPublic FDA data

Ratchet T Handle

Primary DI
07290115934168
Brand
Ratchet T Handle
Company
PREMIA SPINE LTD
Model
85837
Published
2024-10-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K182598000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182598000VersaLink™ Fixation SystemPremia Spine, Ltd.2018-11-13NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290115934168PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290115934168072901159341687290115934168

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, non-torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
649220779
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290014064546VersaLink™ Ring Nut825832026-10-18
07290014064553VersaLink™ Ring Set Screw825822026-10-18
07290014064560VersaLink™ Crossbar826102026-10-18
07290014064959VersaLink™ Ring Set Screw Torx865052026-10-18
07290014080126Fusion Rod 50mm831962026-10-18
07290014080133Fusion Rod 70mm831972026-10-18
07290014080140Fusion Rod 90mm831982026-10-18
07290115932461PER Ring Nut884972026-10-18
07290115932478PER Set Screw Torx884982026-10-18
07290115932874Cannulated Screwdriver inner shaft865082026-10-18
07290115932881Cannulated Screwdriver Handle Assy865102026-10-18
07290115935547Rod Holding Forceps832082024-10-01
07290115932812Left Alignment Gauge Superior Crossbars Long831062024-09-03
07290115932829Right Alignment Gauge Superior Crossbars Long831072024-09-03
07290115932850Left Alignment Gauge Superior Crossbars Medium861872024-09-03
07290115932867Right Alignment Gauge Superior Crossbars Medium861892024-09-03
07290014064973ProMIS™ Fixation System862412015-12-04
07290014064980ProMIS™ Fixation System862422015-12-04
07290014064997ProMIS™ Fixation System862432015-12-04
07290014080003ProMIS™ Fixation System862442015-12-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157122515ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122522ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122539ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122546ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122553ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122560ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122577ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122584ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122591ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122607ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122614ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122621ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122638ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122645ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122652ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122669ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122676ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122683ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122690ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122706ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122713ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122720ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122737ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122744ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122751ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122768ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122775ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122782ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122799ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122805ZAVATION SCREWZavation LLCNKB2026-10-19