FDA.report

S-Wire

Primary DI
B515SSTS165000
Brand
S-Wire
Company
SPINAL RESOURCES, INC.
Model
SSTS16-500
Device description
K-Wire, Single-Trocar, Round Smooth, 1.6 x 500mm (SS)
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

Related Records

Product Codes

CodeName
HTYPin, Fixation, Smooth

Product Code Classifications

CodeDeviceSpecialtyClass
HTYPin, Fixation, SmoothOrthopedic2

Premarket Submissions

SubmissionSupplement
K152662000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K152662000S-WireSpinal Resources, Inc.2016-03-09HTY

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B515SSTS165000PrimaryHIBCC0

GMDN Terms

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
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

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