FDA.reportPublic FDA data

NA

Primary DI
03700569610067
Brand
NA
Company
NEWCLIP TECHNICS
Model
H0.9HFT2.25L18
Catalog number
H0.9HFT2.25L18
Published
2016-09-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K091118000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091118000FOOT AND HAND MOTION SYSTEMNewclip Technics2009-12-16HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700569610067PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700569610067037005696100673700569610067

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, non-sterileA small, non-sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Screws available are: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression. This device must be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
263281904
Device count
1
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
00370056966354NARDT2.8L38D-STRDT2.8L38D-ST2026-07-28
03700569628253NACT3.5L20D-STCT3.5L20D-ST2026-07-28
03700569628277NACT3.5L22D-STCT3.5L22D-ST2026-07-28
03700569641269NAH1.3GLT4.0L70DH1.3GLT4.0L70D2026-07-28
03700569644451NASOT3.5L10DSOT3.5L10D2026-07-28
03700569644468NASOT3.5L12DSOT3.5L12D2026-07-28
03700569644475NASOT3.5L14DSOT3.5L14D2026-07-28
03700569644482NASOT3.5L16DSOT3.5L16D2026-07-28
03700569644499NASOT3.5L18DSOT3.5L18D2026-07-28
03700569644505NASOT3.5L20DSOT3.5L20D2026-07-28
03700569644512NASOT3.5L22DSOT3.5L22D2026-07-28
03700569644529NASOT3.5L24DSOT3.5L24D2026-07-28
03700569644581NACT3.5L20DCT3.5L20D2026-07-28
03700569644598NACT3.5L22DCT3.5L22D2026-07-28
03700569644611NACT3.5L26DCT3.5L26D2026-07-28
03700569652555NACT3.5L32DCT3.5L32D2026-07-28
03700569654757NACT3.5L40DCT3.5L40D2026-07-28
03700569657727NACT2.8L16DCT2.8L16D2026-07-28
03700569657963NACT2.8L40DCT2.8L40D2026-07-28
03700569659219Alians Elbow SNTGY1DNTGY1D2026-07-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00193982101923ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982101947ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
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00193982158378ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158422ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158477ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158521ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158576ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158620ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982158675ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
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00193982167660ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982167714ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
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00193982167912ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982167967ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982168018ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982168063ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982168117ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982175740ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14
00193982175795ANTHEMGLOBUS MEDICAL, INC.HWC2026-08-14