FDA.reportPublic FDA data

Flow-Screw™

Primary DI
B26710213000
Brand
Flow-Screw™
Company
Flow-FX
Model
102-13-00
Catalog number
102-13-00
Device description
FS Length Gauge 4.5mm
Published
2022-02-08
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
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142776000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142776000Flow-ScrewFlow-Fx, LLC2015-03-23HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B26710213000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical depth gauge, reusableA surgical instrument designed to measure the depth of a recess, usually to measure the depth of holes being drilled in bone so that the surgeon can determine the length of the bone screw to be used. It may take two forms: 1) a device with a moveable (sliding) centrepiece (a prong), the tip of which is inserted into the recess to read from a scale; 2) a circular disc with a central hole which is clipped to a drill bit so that the device slides up as the drill bit is advanced. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
079293587
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B2672CAN35002-CAN™2CAN3502CAN3502025-07-11
B267101120Flow-Screw™101-12101-122020-12-18
B267101270Flow-Nail™ 101-27101-272020-12-18
B267101410Flow-Nail™ 101-41101-412020-12-18
B267101540Flow-Nail™ 101-54101-542020-12-18
B26710218000Flow-Screw™102-18-00102-18-002020-12-18
B26710218010Flow-Screw™102-18-01102-18-012020-12-18
B26710218100Flow-Screw™102-18-10102-18-102020-12-18
B26710218110Flow-Screw™102-18-11102-18-112020-12-18
B26710218200Flow-Screw™102-18-20102-18-202020-12-18
B26710218210Flow-Screw™102-18-21102-18-212020-12-18
B2675510700Flow-Screw™55-107055-10702024-07-22
B2675520750Flow-Screw™55-207555-20752024-07-22
B2675510600Flow-Screw™55-106055-10602018-06-22
B2675510650Flow-Screw™55-106555-10652018-06-22
B2675520650Flow-Screw™55-206555-20652018-06-22
B267A600Flow-Nail™A60A602018-06-21
B267C400Flow-Nail™C40C402018-06-22
B267101290Flow-Nail™ 101-29101-292022-02-08
B26710230050Flow-Screw™102-30-05102-30-052024-08-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327697209PANGEAStryker GmbHLXH2026-08-27
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00840606185981ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606185998ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
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00840606186018ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
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00840606186032ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186049ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186056ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186063ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186070ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186087ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
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00840606186100ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186117ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
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00840606186162ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
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00840606186186ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
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00840606186414ALIFSPINAL ELEMENTS, INC.LXH2026-08-26