FDA.reportPublic FDA data

GEO Bone Screw System

Primary DI
B471270002300
Brand
GEO Bone Screw System
Company
GRAMERCY EXTREMITY ORTHOPEDICS LLC
Model
27000230
Device description
Depth Gauge for 230mm Guide Wire
Published
2018-10-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTJGAUGE, DEPTH

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTJGauge, DepthOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161904000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161904000GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC2017-01-18HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B471270002300PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical depth gauge, single-useA sterile 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 single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-10 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855)436-2278GEOSupportCenter@gramercyortho
+1(855)436-2278GEOSupportCenter@gramercyortho.com

Regulatory Flags#

DUNS number
080068420
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B471120301040Lapidus Plating System120301042023-07-17
B471120302050Lapidus Plating System120302052023-07-17
B471120303050Lapidus Plating System120303052023-07-17
B471123301040Lapidus Plating System123301042023-07-17
B471123302050Lapidus Plating System123302052023-07-17
B471123303050Lapidus Plating System123303052023-07-17
B471126300040Lapidus Plating System126300042023-07-17
B471126600050Distal Fibula Plating System126600052022-01-10
B471126600070Distal Fibula Plating System126600072022-01-10
B471126600090Distal Fibula Plating System126600092022-01-10
B471126600110Distal Fibula Plating System126600112022-01-10
B471126601050Distal Fibula Plating System126601052022-01-10
B471126601070Distal Fibula Plating System126601072022-01-10
B471126601090Distal Fibula Plating System126601092022-01-10
B471126601110Distal Fibula Plating System126601112022-01-10
B471120200000FirstFUSE 1st MTP Joint Plating System120200002020-10-23
B471120200050FirstFUSE 1st MTP Joint Plating System120200052020-10-23
B471120200500FirstFUSE 1st MTP Joint Plating System120200502020-10-23
B471120200550FirstFUSE 1st MTP Joint Plating System120200552020-10-23
B471120201000FirstFUSE 1st MTP Joint Plating System120201002020-10-23

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Primary DI, Brand, Company table
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08809513720359SAEHAN Mechanical Pinch GaugeSaehan CorporationHTJ2026-05-18
08800322750001AnyPlus®GS Medical Co., Ltd.HTJ2026-04-21
10850070500484Cannulated Depth Guage CURVAFIX, INC.HTJ2025-10-22
00810135963404ImpactNVision Biomedical Technologies, Inc.HTJ2025-09-24
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