FDA.reportPublic FDA data

Xpert PFP

Primary DI
03700569663964
Brand
Xpert PFP
Company
NEWCLIP TECHNICS
Model
QTSM3D-ST
Catalog number
QTSM3D-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
03700569663964PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700569663964037005696639643700569663964

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
03700569638306NASAT3.5L22SAT3.5L222024-11-15
03700569638313NASAT3.5L22-STSAT3.5L22-ST2024-11-15
03700569638320NASAT3.5L24SAT3.5L242024-11-15
03700569638337NASAT3.5L24-STSAT3.5L24-ST2024-11-15
03700569638344NASAT3.5L26SAT3.5L262024-11-15
03700569638351NASAT3.5L26-STSAT3.5L26-ST2024-11-15
03700569638368NASAT3.5L28SAT3.5L282024-11-15
03700569638375NASAT3.5L28-STSAT3.5L28-ST2024-11-15
03700569638382NASAT3.5L30SAT3.5L302024-11-15
03700569638399NASAT3.5L30-STSAT3.5L30-ST2024-11-15
03700569638405NASAT3.5L32SAT3.5L322024-11-15
03700569638412NASAT3.5L32-STSAT3.5L32-ST2024-11-15
03700569638429NASAT3.5L36SAT3.5L362024-11-15
03700569638436NASAT3.5L36-STSAT3.5L36-ST2024-11-15
03700569638443NASAT3.5L38SAT3.5L382024-11-15
03700569638450NASAT3.5L38-STSAT3.5L38-ST2024-11-15
03700569638467NASAT3.5L40SAT3.5L402024-11-15
03700569638474NASAT3.5L40-STSAT3.5L40-ST2024-11-15
03700569648770NASAT3.5L34SAT3.5L342024-11-15
03700569648787NASAT3.5L34-STSAT3.5L34-ST2024-11-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08809986485144CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485151CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485168CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485274CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485281CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485298CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485304CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485311CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485328CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485335CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485342CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485359CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485366CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485373CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485380CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485397CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485403CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485410CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485427CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485434CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485441CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485458CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485465CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485472CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485588CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485595CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485601CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485618CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29
08809986485625CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-29