FDA.reportPublic FDA data

SkyOPS

Primary DI
00850024702301
Brand
SkyOPS
Company
Sky Surgical, LLC
Model
001-1-26
Device description
Drill Tower, Proximal (ø2.0mm)
Published
2024-09-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FZXGuide, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850024702301PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850024702301008500247023018500247023010850024702301

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic intraoperative positioning pin, reusableA nonimplantable device in the form of a thin rod intended to be drilled into bone to assist with the positioning of an implantable device and/or surgical instrument (e.g., fixation plate, drill guide) during an orthopaedic procedure. It is also referred to as a wire or temporary K-wire. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
945017205
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850024702523SkyOPSS00062026-05-11
00850024702530SkyOPSS00092026-05-11
00850024702554SkyOPSS00152026-05-07
00850024702561SkyOPSS00212026-05-07
00850024702578SkyOPSS00222026-05-07
00850024702004SkyOPSP0001L2024-09-23
00850024702011SkyOPSP0001R2024-09-23
00850024702028SkyOPSP00022024-09-23
00850024702035SkyOPSP0003L 2024-09-23
00850024702042SkyOPSP0003R 2024-09-23
00850024702059SkyOPS24-008-N2024-09-23
00850024702066SkyOPS24-010-N2024-09-23
00850024702073SkyOPS24-012-N2024-09-23
00850024702080SkyOPS24-014-N2024-09-23
00850024702097SkyOPS24-016-N2024-09-23
00850024702103SkyOPS24-018-N2024-09-23
00850024702110SkyOPS24-020-N2024-09-23
00850024702127SkyOPS24-022-N2024-09-23
00850024702134SkyOPS24-024-N2024-09-23
00850024702141SkyOPS24-026-N2024-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10886982350633VOLTSynthes GmbHFZX2026-09-25
10886982350640VOLTSynthes GmbHFZX2026-09-25
10886982350657VOLTSynthes GmbHFZX2026-09-25
10886982350664VOLTSynthes GmbHFZX2026-09-25
10886982350671VOLTSynthes GmbHFZX2026-09-25
10886982350688VOLTSynthes GmbHFZX2026-09-25
10886982351098VOLTSynthes GmbHFZX2026-09-25
10886982351104VOLTSynthes GmbHFZX2026-09-25
10886982351111VOLTSynthes GmbHFZX2026-09-25
10886982351128VOLTSynthes GmbHFZX2026-09-25
10886982351135VOLTSynthes GmbHFZX2026-09-25
10886982351142VOLTSynthes GmbHFZX2026-09-25
10886982351692VOLTSynthes GmbHFZX2026-09-25
10886982357182VOLTSynthes GmbHFZX2026-09-25
00190776432164MillenniumAvalign Technologies, Inc.FZX2026-09-22
00810111228527Drill GuideTreace Medical Concepts, Inc.FZX2026-09-21
00190776423896MillenniumAvalign Technologies, Inc.FZX2026-08-26
10886982362988NASynthes GmbHFZX2026-08-26
10886982362995NASynthes GmbHFZX2026-08-26
10886982363008NASynthes GmbHFZX2026-08-26
10886982363015NASynthes GmbHFZX2026-08-26
008890247114712.9 JuggerKnot Self-Punching ObturatorZimmer, Inc.FZX2026-08-25
008890247114882.9 JuggerKnot Self-Punching CannulaZimmer, Inc.FZX2026-08-25
00889024712294Pin Target AssemblyZimmer, Inc.FZX2026-08-25
06937278653598CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278653604CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278653611CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278653628CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654250CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654267CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22