FDA.reportPublic FDA data

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

Primary DI
04719878786768
Brand
“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)
Company
Paonan Biotech Co.,Ltd.
Model
406-0810
Catalog number
406-0810
Device description
Rod Pusher
Published
2024-04-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HXOPusher, Socket

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXOPusher, SocketOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719878786768PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719878786768047198787867684719878786768

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic rod reducerA heavy-duty, hand-held manual surgical instrument intended to be used to reduce or seat an implantable rod into the saddle of an implant (i.e., bone screw, spinal hook) used as a component of a system to apply force to a series of vertebrae to correct scoliosis (lateral curvature of the spine) or other spinal conditions. When the rod lies medial or lateral to the implant channel this instrument allows for controlled translation of the rod into the saddle of the screws and/or hooks. The surgeon is able to control the positioning (bending) of the rod into the saddle. Once the rod is securely seated in the saddle it is locked into position with a plug or a setscrew. This is a reusable device.

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850011453537Remedy Poly+Plus Acetabular CupOSTEOREMEDIES, LLCHXO2026-06-01
108500705004914.0mm Dual Obturator CURVAFIX, INC.HXO2025-10-22
04719878788106“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)Paonan Biotech Co.,Ltd.HXO2025-10-15
04262494460739N/ADoppkon GmbH & Co. KGHXO2025-09-10
04262494460746N/ADoppkon GmbH & Co. KGHXO2025-09-10
04262494460753N/ADoppkon GmbH & Co. KGHXO2025-09-10
04052536081417uCentumUlrich GmbH & Co. KGHXO2025-07-30
10810128461310Hip, Curved Knot PusherT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHXO2025-04-29
08800089448739Surgical InstrumentJeil Medical CorporationHXO2024-11-14
00887868582134Affixus®Zimmer, Inc.HXO2024-10-17
00887868582325Affixus®Zimmer, Inc.HXO2024-10-17
08800247360118ANAX™ 5.5 SPINAL SYSTEMCG MedTech Co.,Ltd.HXO2024-04-26
00613994594891Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXO2023-07-27
08809763500411MEGA SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-23
08809763500510MEGA SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-23
08809763500527MEGA SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-23
08809763500909MEGA SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-23
08809763501050MEGA SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-23
08809763501357MEGA SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-23
08809763501364MEGA5.5 SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-23
08809763501388MEGA SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-23
08809763501395MEGA5.5 SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-23
08809763501425MEGA5.5 SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-23
08809763501432MEGA SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-23
08809763505317MEGA5.5 SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-23
08809763500176MEGA PLUS SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-14
08809763500183MEGA SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-14
08809763501333MEGA PLUS SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-14
08809763505188MEGA5.5 SPINE SYSTEMBK MEDITECH CO.,LTD.HXO2023-06-14
00887868567490Closed Knot PusherBiomet Orthopedics, LLCHXO2023-05-29