FDA.reportPublic FDA data

Rod Bender

Primary DI
07290115935479
Brand
Rod Bender
Company
PREMIA SPINE LTD
Model
86297
Published
2024-10-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIOrthosis, Spinal Pedicle Fixation
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150380000
K170061000
K182598000
K231844000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150380000ProMIS Fixation SystemPremia Spine, Ltd.2015-07-17NKB
K170061000ProMIS™ Fixation SystemPremia Spine, Ltd.2017-02-02NKB
K182598000VersaLink™ Fixation SystemPremia Spine, Ltd.2018-11-13NKB
K231844000ProMIS™ Fixation SystemPremia Spine, Ltd.2023-07-07NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290115935479PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290115935479072901159354797290115935479

GMDN Terms#

Term, Definition table
TermDefinition
Manual orthopaedic bender, reusableA manually-operated surgical instrument designed to bend orthopaedic devices, typically those for implantation (e.g., orthopaedic rods, bone fixation plates), to an appropriate anatomical shape. The bending process is typically performed within the operating room (OR), inside or outside of the operative sterile field. The device may be hand held or table mounted. 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