FDA.reportPublic FDA data

S-Wire

Primary DI
B515NSTS165000
Brand
S-Wire
Company
SPINAL RESOURCES, INC.
Model
NSTS16-500
Device description
K-Wire, Single-Trocar, Round Smooth, 1.6 x 500 mm (Nitinol)
Published
2018-03-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
K152662000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152662000S-WireSpinal Resources, Inc.2016-03-09HTY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B515NSTS165000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone wireA wire intended for the fixation of bone fractures that may be implanted or used short-term (e.g., to hold a plate in the correct position during an intervention). It may be used: 1) as a cerclage wire to aid bone fixation; 2) in a loop or figure-of-eight configuration to reattach, e.g., the tip of the elbow (olecranon), tibial tubercle, or greater trochanter; 3) to augment bone screw/plate fixation; or 4) as a Kirschner wire or K-Wire to stiffen (arthrodese) a toe or finger. It is made of metal [e.g., stainless steel, cobalt-chrome (Co-Cr)], and may be malleable or rigid; some types include a nut designed to be attached to the wire to prevent wire migration. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
018255727
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
true
Expiration date on label
false
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
B515RSTT47555450Swedge Pedicle Screw Fixation SystemRSTT47555-4502024-12-25
B515RSTT47555500Swedge Pedicle Screw Fixation SystemRSTT47555-5002024-12-25
B515RSTTC3005511Swedge Pedicle Screw Fixation SystemRSTTC-300-55112024-02-09
B515RSCTT47555120Swedge Pedicle Screw Fixation SystemRSCTT47555-1202024-07-29
B515RSCTT47555140Swedge Pedicle Screw Fixation SystemRSCTT47555-1402024-07-29
B515SPSCT6545Swedge Pedicle Screw Fixation SystemSPSCT65452024-07-29
B515SPSCT6550Swedge Pedicle Screw Fixation SystemSPSCT65502024-07-29
B515LC030Swedge Pedicle Screw Fixation SystemLC-032020-06-08
B515LC040Swedge Pedicle Screw Fixation SystemLC-042020-06-08
B515RSTT47555060Swedge Pedicle Screw Fixation SystemRSTT47555-0602024-02-09
B515RSTT47555070Swedge Pedicle Screw Fixation SystemRSTT47555-0702024-02-09
B515RSTT47555080Swedge Pedicle Screw Fixation SystemRSTT47555-0802024-02-09
B515RSTT47555090Swedge Pedicle Screw Fixation SystemRSTT47555-0902024-02-09
B515RSTT47555100Swedge Pedicle Screw Fixation SystemRSTT47555-1002024-02-09
B515RSTT47555120Swedge Pedicle Screw Fixation SystemRSTT47555-1202024-06-12
B515RSTT47555250Swedge Pedicle Screw Fixation SystemRSTT47555-2502024-06-12
B515RSCTT47555110Swedge Pedicle Screw Fixation SystemRSCTT47555-1102024-05-20
B515RSCTT47555130Swedge Pedicle Screw Fixation SystemRSCTT47555-1302024-05-20
B515RSCTT47555150Swedge Pedicle Screw Fixation SystemRSCTT47555-1502024-05-20
B515RSTT47555110Swedge Pedicle Screw Fixation SystemRSCTT47555-1102024-05-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
24053613265496Steinmann PinGebr. Brasseler GmbH & Co. KGHTY2026-03-20
00888867516533Arthrex®ARTHREX, INC.HTY2026-03-13
00888867516564Arthrex®ARTHREX, INC.HTY2026-03-13
00888867516601Arthrex®ARTHREX, INC.HTY2026-03-13
00888867543188Arthrex®ARTHREX, INC.HTY2026-03-13
00888867543270Arthrex®ARTHREX, INC.HTY2026-03-13
00888867543287Arthrex®ARTHREX, INC.HTY2026-03-13
00888867543294Arthrex®ARTHREX, INC.HTY2026-03-13
00888867543317Arthrex®ARTHREX, INC.HTY2026-03-13
00888867543324Arthrex®ARTHREX, INC.HTY2026-03-13
00888867543485Arthrex®ARTHREX, INC.HTY2026-03-13
00888867543621Arthrex®ARTHREX, INC.HTY2026-03-13
00888867543652Arthrex®ARTHREX, INC.HTY2026-03-13
00888867543669Arthrex®ARTHREX, INC.HTY2026-03-13
00888867543683Arthrex®ARTHREX, INC.HTY2026-03-13
00888867543812Arthrex®ARTHREX, INC.HTY2026-03-13
00888867543829Arthrex®ARTHREX, INC.HTY2026-03-13
00888867543850Arthrex®ARTHREX, INC.HTY2026-03-13
00888867543874Arthrex®ARTHREX, INC.HTY2026-03-13
24026704912432KMEDICTELEFLEX INCORPORATEDHTY2026-02-06
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06438394000025ActivaPin™Bioretec OyHTY2026-02-05
06438394000032ActivaPin™Bioretec OyHTY2026-02-05
06438394000049ActivaPin™Bioretec OyHTY2026-02-05
06438394000056ActivaPin™Bioretec OyHTY2026-02-05
06438394000063ActivaPin™Bioretec OyHTY2026-02-05
06438394000070ActivaPin™Bioretec OyHTY2026-02-05
06438394000087ActivaPin™Bioretec OyHTY2026-02-05
06438394000094ActivaPin™Bioretec OyHTY2026-02-05
06438394000100ActivaPin™Bioretec OyHTY2026-02-05