FDA.reportPublic FDA data

Alians Forearm

Primary DI
03700569602932
Brand
Alians Forearm
Company
NEWCLIP TECHNICS
Model
ETSIS2
Catalog number
ETSIS2
Published
2024-11-14
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
HRSPlate, Fixation, Bone

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170843000
K262649000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170843000Alians Fragment SpecificNewclip Technics2017-06-16HRS
K262649000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700569602932PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700569602932037005696029323700569602932

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.

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
03700569602918Alians ForearmETSIS1ETSIS12024-11-14
03700569602925Alians ForearmETSIS1-STETSIS1-ST2024-11-14
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
03700569604295NAQOT3.5L16-STQOT3.5L16-ST2024-11-15
03700569604318NAQOT3.5L18-STQOT3.5L18-ST2024-11-15
03700569604332NAQOT3.5L20-STQOT3.5L20-ST2024-11-15
03700569604356NAQOT3.5L22-STQOT3.5L22-ST2024-11-15
03700569604370NAQOT3.5L24-STQOT3.5L24-ST2024-11-15
03700569633936NAQBT2.8L18QBT2.8L182024-11-15
03700569633950NAQBT2.8L20QBT2.8L202024-11-15
03700569633974NAQBT2.8L22QBT2.8L222024-11-15
03700569633998NAQBT2.8L24QBT2.8L242024-11-15
03700569634018NAQBT2.8L26QBT2.8L262024-11-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809986482501CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-09-22
08809986482518CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-09-22
08809986482525CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-09-22
08809986482532CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-09-22
08809986482549CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-09-22
08809986482556CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-09-22
08809986482563CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-09-22
08809986482570CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-09-22
08809986482587CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-09-22
03700569602918Alians ForearmNEWCLIP TECHNICSHRS2024-11-14
03700569602925Alians ForearmNEWCLIP TECHNICSHRS2024-11-14
03700569602949Alians ForearmNEWCLIP TECHNICSHRS2024-11-14
03700569602956Alians ForearmNEWCLIP TECHNICSHRS2024-11-14
03700569602963Alians ForearmNEWCLIP TECHNICSHRS2024-11-14
03700569602970Alians ForearmNEWCLIP TECHNICSHRS2024-11-14
03700569602987Alians ForearmNEWCLIP TECHNICSHRS2024-11-14
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00885556819852Uni-CP Compression PlateSmith & Nephew, Inc.HRS2023-11-07
00885556819869Uni-CP Compression PlateSmith & Nephew, Inc.HRS2023-11-07
00885556819876Uni-CP Compression PlateSmith & Nephew, Inc.HRS2023-11-07
00885556819883Uni-CP Compression PlateSmith & Nephew, Inc.HRS2023-11-07
00885556819890Uni-CP Compression PlateSmith & Nephew, Inc.HRS2023-11-07
00885556819906Uni-CP Compression PlateSmith & Nephew, Inc.HRS2023-11-07
00885556846599Total Wrist FusionSmith & Nephew, Inc.HRS2023-10-27
00885556910245UNI-CP Compression PlateSmith & Nephew, Inc.HRS2023-10-27
00885556819722Total Wrist FusionSmith & Nephew, Inc.HRS2023-10-26
00885556819746Total Wrist FusionSmith & Nephew, Inc.HRS2023-10-26
00885556819760Total Wrist FusionSmith & Nephew, Inc.HRS2023-10-26
00885556819784UNI-CP Compression PlateSmith & Nephew, Inc.HRS2023-10-26
00885556819791UNI-CP Compression PlateSmith & Nephew, Inc.HRS2023-10-26