FDA.reportPublic FDA data

Threaded Hand Nail

Primary DI
00841506141428
Brand
Threaded Hand Nail
Company
SKELETAL DYNAMICS L.L.C.
Model
KWIR-ST-07152
Catalog number
KWIR-ST-07152
Device description
K-Wire, 0.7mm x 152mm, Single Trocar
Published
2026-04-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTYPIN, FIXATION, SMOOTH

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTYPin, Fixation, SmoothOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230908000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230908000Hand Trauma Threaded Nail SystemSkeletal Dynamics, Inc.2023-04-28HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841506141428PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841506141428008415061414288415061414280841506141428

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone pin, non-bioabsorbableA thin, implantable rod intended to be used for the stabilization of a bone fracture or bone grafts, or for an osteotomy or arthrodesis (internal and/or external fixation). It is typically drilled into bone and may be smooth or threaded, solid or cannulated, and/or semi-flexible. Also known as a Kirschner-wire (K-wire), it may in addition be intended to assist with the introduction of a surgical instrument and/or implant; it is not intended for implantation into the intramedullary canal (i.e., not a nail). It is made of a non-bioabsorbable material (e.g., stainless steel). Some designs may have a break-off shank and/or be coated to improve long-term fixation. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(305)596-7585feedback@skeletaldynamics.com

Regulatory Flags#

DUNS number
869056148
Device count
1
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841506134895Threaded Hand NailDGA-THN-20DGA-THN-202026-04-29
00841506140193Threaded Hand NailDRVR-UQC-T8RDRVR-UQC-T8R2026-04-29
00841506140216Threaded Hand NailDRVR-CAN-T10RDRVR-CAN-T10R2026-04-29
00841506140223Threaded Hand NailDRVR-CAN-T8RDRVR-CAN-T8R2026-04-29
00841506141060Threaded Hand NailKWIR-DT-14171KWIR-DT-141712026-04-29
00841506141398Threaded Hand NailHTS-WPHTS-WP2026-04-29
00841506146546Threaded Hand NailRHS-20012CRHS-20012C2026-04-29
00841506146553Threaded Hand NailRHS-20014CRHS-20014C2026-04-29
00841506146560Threaded Hand NailRHS-20016CRHS-20016C2026-04-29
00841506146577Threaded Hand NailRHS-20018CRHS-20018C2026-04-29
00841506146584Threaded Hand NailRHS-20020CRHS-20020C2026-04-29
00841506146591Threaded Hand NailRHS-20022CRHS-20022C2026-04-29
00841506146607Threaded Hand NailRHS-20024CRHS-20024C2026-04-29
00841506146614Threaded Hand NailRHS-20026CRHS-20026C2026-04-29
00841506146621Threaded Hand NailRHS-20028CRHS-20028C2026-04-29
00841506146638Threaded Hand NailRHS-20032CRHS-20032C2026-04-29
00841506146645Threaded Hand NailRHS-20036CRHS-20036C2026-04-29
00841506146652Threaded Hand NailRHS-20040CRHS-20040C2026-04-29
00841506146669Threaded Hand NailRHS-20044CRHS-20044C2026-04-29
00841506146676Threaded Hand NailRHS-20048CRHS-20048C2026-04-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07649990202419Drill S-PI-A1.6 extra shortSurgical Fusion Technologies GmbHHTY2026-01-18
07649990202174Geomax Reamer S-PI-A1.6Surgical Fusion Technologies GmbHHTY2025-10-01
07649990202211Geomax Reamer S-PI-A2.3Surgical Fusion Technologies GmbHHTY2025-10-01
07649990202372Geomax Reamer S-PI-A3.0Surgical Fusion Technologies GmbHHTY2025-10-01
07649990202389Handle SSurgical Fusion Technologies GmbHHTY2025-10-01
07649990202396Geomax Reamer SetSurgical Fusion Technologies GmbHHTY2025-10-01
07630037863977APTUSMedartis AGHTY2025-07-31
07630037863984APTUSMedartis AGHTY2025-07-31
07630037864011APTUSMedartis AGHTY2025-04-08
07630037864264APTUSMedartis AGHTY2025-04-08
07613327084191STEINMANNStryker GmbHHTY2025-01-09
07649990202075SupraFuser GeneratorSurgical Fusion Technologies GmbHHTY2024-04-12
07649990202228SF Push-in Anchor 1.6Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202235SF Push-in Anchor 3.0Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202259Stopper S-PI-A1.6Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202266Stopper S-PI-A2.3Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202273Stopper S-PI-A3.0Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202297Guide S-PI / W5.0Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202303Sonotrode S-PISurgical Fusion Technologies GmbHHTY2024-04-12
07649990202310Drill S-PI-A1.6Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202327Drill S-PI-A2.3Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202334Drill S-PI-A3.0Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202365Tray SF Push-in Anchor PortfolioSurgical Fusion Technologies GmbHHTY2024-04-12
07630037863854APTUSMedartis AGHTY2024-03-22
07630037863915APTUSMedartis AGHTY2024-03-22
07630037864196APTUSMedartis AGHTY2024-03-22
07630037864226APTUSMedartis AGHTY2024-03-22
07630037864233APTUSMedartis AGHTY2024-03-22
07649990202204SupraFuser B GeneratorSurgical Fusion Technologies GmbHHTY2024-02-06
07649990202082Handpiece SupraFuserSurgical Fusion Technologies GmbHHTY2024-02-05