FDA.reportPublic FDA data

“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)

Primary DI
04719878789738
Brand
“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)
Company
Paonan Biotech Co.,Ltd.
Model
NSC-2608
Catalog number
NSC-2608
Device description
NEST-C Convex Trial W16*H8
Published
2026-05-11
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
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719878789738PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719878789738047198787897384719878789738

GMDN Terms#

Term, Definition table
TermDefinition
Spinal implant trialA copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height8Millimeter
Width16Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
657397790
Device count
1
Premarket exempt
true
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
04719878789745“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)NSC-2609NSC-26092026-05-11
04719899787973“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)420-0011C420-0011C2026-05-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809986489425LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-08-19
08809986489432LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-08-19
M9432002230000Liberty SISpinal Simplicity, LLCLXH2026-08-19
00198506093937ELMED INCORPORATEDELMED INCORPORATEDLXH2026-08-18
00198506094194ELMED INCORPORATEDELMED INCORPORATEDLXH2026-08-18
00810130207534MSIModern Surgical Instruments LLCLXH2026-08-18
00810198920345General InstrumentsTheraMicro, LLCLXH2026-08-18
00810198920352TeKForceTheraMicro, LLCLXH2026-08-18
00810198920376TeKForceTheraMicro, LLCLXH2026-08-18
00850078396396ActivaScrew™ Cannulated COM Single-Use Accessory Kit 3.5/4.0/4.5 mm(1054)Eca Medical InstrumentsLXH2026-08-18
08053782781652Bioplan Instruments KitBRM EXTREMITIES SRLLXH2026-08-18
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08057717553642BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553659BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
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08057717553697BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553703BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553710BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
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08800322750834PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.LXH2026-08-18
08800322758106PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.LXH2026-08-18
08800322758113PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.LXH2026-08-18
08800322759523QUASAR Standalone ACIF SystemGS Medical Co., Ltd.LXH2026-08-18
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