Xpert PFP

Primary DI
03700569676445
Brand
Xpert PFP
Company
NEWCLIP TECHNICS
Model
QTDPH2D-ST
Catalog number
QTDPH2D-ST
Published
2026-06-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HRSPlate, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K261038000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K261038000Xpert PFPNewclip Technics2026-05-29HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700569676445PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700569676445037005696764453700569676445

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, non-bioabsorbableA non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws, and may be used in connection with another fixation plate; it does not incorporate a sleeve or blade. Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate.

Regulatory Flags#

DUNS number
263281904
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03700569631840Alians ForearmHTSIS2HTSIS22026-10-01
03700569631857Alians ForearmHTSIS2-STHTSIS2-ST2026-10-01
03700569633943NAQBT2.8L18-STQBT2.8L18-ST2026-10-01
03700569633967NAQBT2.8L20-STQBT2.8L20-ST2026-10-01
03700569633981NAQBT2.8L22-STQBT2.8L22-ST2026-10-01
03700569634001NAQBT2.8L24-STQBT2.8L24-ST2026-10-01
03700569634025NAQBT2.8L26-STQBT2.8L26-ST2026-10-01
03700569634049NAQBT2.8L28-STQBT2.8L28-ST2026-10-01
03700569634063NAQBT2.8L30-STQBT2.8L30-ST2026-10-01
03700569602918Alians ForearmETSIS1ETSIS12024-11-14
03700569602925Alians ForearmETSIS1-STETSIS1-ST2024-11-14
03700569602932Alians ForearmETSIS2ETSIS22024-11-14
03700569602949Alians ForearmETSIS2-STETSIS2-ST2024-11-14
03700569602956Alians ForearmETSIS3ETSIS32024-11-14
03700569602963Alians ForearmETSIS3-STETSIS3-ST2024-11-14
03700569602970Alians ForearmETSIS4ETSIS42024-11-14
03700569602987Alians ForearmETSIS4-STETSIS4-ST2024-11-14
03700569604233NAQOT3.5L10-STQOT3.5L10-ST2024-11-15
03700569604257NAQOT3.5L12-STQOT3.5L12-ST2024-11-15
03700569604271NAQOT3.5L14-STQOT3.5L14-ST2024-11-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05055662976649Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-10-06
05055662976656Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-10-06
05055662976663Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-10-06
05055662976670Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-10-06
05055662976687Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-10-06
03700569631840Alians ForearmNEWCLIP TECHNICSHRS2026-10-01
03700569631857Alians ForearmNEWCLIP TECHNICSHRS2026-10-01
00888118131867LEVEL ONE EXTREMITY, STERILEKLS-Martin L.P.HRS2026-04-23
00810112599268TriLEAPCROSSROADS EXTREMITY SYSTEMSHRS2025-03-17
00810112593341TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHRS2024-02-22
00885556838211Total Foot System 2Smith & Nephew, Inc.HRS2023-04-18
00815432024322DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2022-12-09
00815432024339DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2022-12-09
00815432024346DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2022-11-30
B562PKSMC0835NSLTIUS0Superior Mid-Shaft Narrow Straight Clavicle Plate Procedure Kit 8 hole, LeftWishbone Medical, Inc.HRS2019-09-06
B562PKSMC0835NSRTIUS0Superior Mid-Shaft Narrow Straight Clavicle Plate Procedure Kit 8 hole, RightWishbone Medical, Inc.HRS2019-09-06
00842188115424Radial Shortening PlateTrimed, INC.HRS2017-05-19
00842188115431Radial Shortening PlateTrimed, INC.HRS2017-05-19
00842188116636Locking PlatesTrimed, INC.HRS2017-05-19
00842188116643Locking PlatesTrimed, INC.HRS2017-05-19
00842188116650Locking PlatesTrimed, INC.HRS2017-05-19
00815432023592DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2017-04-10
00815432023608DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2017-04-10
00815432023615DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2017-04-10
00815432023622DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2017-04-10
00815432023639DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2017-04-10
00815432023646DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2017-04-10
00815432023653DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2017-04-10
00815432023660DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2017-04-10
00815432023677DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHRS2017-04-10