FDA.reportPublic FDA data

TREND II Spinal Fixation System- STEP Series

Primary DI
04719884695283
Brand
TREND II Spinal Fixation System- STEP Series
Company
Paonan Biotech Co.,Ltd.
Model
1226-4525
Catalog number
1226-4525
Device description
Multiaxial Cannulated Screw, D 4.50 x L 25 mm
Published
2025-02-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
K180226000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180226000TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.2018-07-25NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719884695283PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719884695283047198846952834719884695283

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length25Millimeter
Outer Diameter4.5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
657397790
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04710281445723“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)NSC-0200NSC-02002026-05-11
04710281445792“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)NSC-0104NSC-01042026-05-11
04719878789400“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)NSC-0100NSC-01002026-05-11
04719878789417“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)NSC-0101NSC-01012026-05-11
04719878789424“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)NSC-0102NSC-01022026-05-11
04719878789431“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)NSC-0103NSC-01032026-05-11
04719878789455“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)NSC-0001NSC-00012026-05-11
04719878789462“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)NSC-0002NSC-00022026-05-11
04719878789509“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)420-0010420-00102026-05-11
04719878789530“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)420-0013420-00132026-05-11
04719878789653“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)NSC-2405NSC-24052026-05-11
04719878789660“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)NSC-2406NSC-24062026-05-11
04719878789677“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)NSC-2407NSC-24072026-05-11
04719878789684“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)NSC-2408NSC-24082026-05-11
04719878789691“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)NSC-2409NSC-24092026-05-11
04719878789707“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)NSC-2605NSC-26052026-05-11
04719878789714“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)NSC-2606NSC-26062026-05-11
04719878789721“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)NSC-2607NSC-26072026-05-11
04719878789738“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)NSC-2608NSC-26082026-05-11
04719878789745“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)NSC-2609NSC-26092026-05-11

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840493422626RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422633RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
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00840493422657RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422664RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422671RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422688RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
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00840493422725RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422732RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422749RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422756RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422763RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422770RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422787RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422794RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422800RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
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00840493422848RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422855RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422862RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422879RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422886RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05