FDA.reportPublic FDA data

Footmotion Plating System

Primary DI
03700569653934
Brand
Footmotion Plating System
Company
NEWCLIP TECHNICS
Model
CAT2.8L16D
Catalog number
CAT2.8L16D
Published
2024-11-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
HWCScrew, Fixation, Bone

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221395000
K261511000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221395000Footmotion Plating SystemNewclip Technics2022-07-01HRS
K261511000Xpert AnkleNewclip Technics2026-07-28HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700569653934PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700569653934037005696539343700569653934

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03700569653880Footmotion Plating SystemCAT2.8L10D-STCAT2.8L10D-ST2024-11-13
03700569653897Footmotion Plating SystemCAT2.8L12DCAT2.8L12D2024-11-13
03700569653903Footmotion Plating SystemCAT2.8L12D-STCAT2.8L12D-ST2024-11-13
03700569653910Footmotion Plating SystemCAT2.8L14DCAT2.8L14D2024-11-13
03700569653927Footmotion Plating SystemCAT2.8L14D-STCAT2.8L14D-ST2024-11-13
03700569653941Footmotion Plating SystemCAT2.8L16D-STCAT2.8L16D-ST2024-11-13
03700569653958Footmotion Plating SystemCAT2.8L18DCAT2.8L18D2024-11-13
03700569653965Footmotion Plating SystemCAT2.8L18D-STCAT2.8L18D-ST2024-11-13
03700569679262Newclip InstrumentsANC1616ANC16162026-10-30
03700569679279Newclip InstrumentsANC1618ANC16182026-10-30
03700569679286Newclip InstrumentsANC1618-STANC1618-ST2026-10-30
03700569679293Newclip InstrumentsANC1619ANC16192026-10-30
03700569679309Newclip InstrumentsANC1619-STANC1619-ST2026-10-30
03700569680121Newclip InstrumentsANC1881ANC18812026-10-30
03700569680138Newclip InstrumentsANC1881-STANC1881-ST2026-10-30
03700569682460Newclip InstrumentsANC1617ANC16172026-10-30
03700569682514Newclip InstrumentsANC1647/M5ANC1647/M52026-10-30
03700569683030Newclip InstrumentsANC1899ANC18992026-10-30
03700569683047Newclip InstrumentsANC1900ANC19002026-10-30
03700569683054Newclip InstrumentsANC1900-STANC1900-ST2026-10-30

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