FDA.reportPublic FDA data

GEO Bone Screw System

Primary DI
B471230000360
Brand
GEO Bone Screw System
Company
GRAMERCY EXTREMITY ORTHOPEDICS LLC
Model
23000036
Device description
Countersink, Cannulated, AO, 3.6mm
Published
2019-07-25
Public version status
New
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
HWWCOUNTERSINK

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWWCountersinkOrthopedic1

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
B471230000360PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical countersink, single-useA rotary surgical instrument designed to enlarge the diameter of the proximal portion of a hole drilled in bone. It is a shaft of metal with a cutting head, available in various configurations, that is rotated at low speeds typically by a drilling system. The device is typically used to recess the head of a screw/bolt within bone (enable it to lie flush with or below the bone surface) or to help accommodate the implantation of a device in bone. This is a single-use device intended to be sterilized prior to use.

Storage And Handling#

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

Contacts#

Phone, Email table
PhoneEmail
+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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03700569679170Newclip InstrumentsNEWCLIP TECHNICSHWW2026-05-05
03700569679187Newclip InstrumentsNEWCLIP TECHNICSHWW2026-05-05
00810211043945Ultra Compression Screw SystemPace Surgical, Inc.HWW2026-04-27
00810211043952Ultra Compression Screw SystemPace Surgical, Inc.HWW2026-04-27
00810211043969Ultra Compression Screw SystemPace Surgical, Inc.HWW2026-04-27
00810211043976Ultra Compression Screw SystemPace Surgical, Inc.HWW2026-04-27
00810211043983Ultra Compression Screw SystemPace Surgical, Inc.HWW2026-04-27
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00810211044010Ultra Compression Screw SystemPace Surgical, Inc.HWW2026-04-27
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10888277373754MEDLINEMEDLINE INDUSTRIES, INC.HWW2025-02-21
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