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GEO Bone Screw System

FDA UDI

Class I (US FDA UDI)

by Gramercy Extremity Orthopedics, Llc.

Identity

Trade Name
GEO Bone Screw System FDA UDI
Generic Name
Orthopaedic surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
K-Wire Pack (2) 1.6mmx150mm for 4mm/5mm Bone Screw FDA UDI
Model / Reference
71130004 FDA UDI
Description
K-Wire Pack (2) 1.6mmx150mm for 4mm/5mm Bone Screw FDA UDI

Identifiers

Primary DI / UDI-DI
B471711300040 FDA UDI
510(k) Number
K161904 FDA UDI
FDA Product Code
KDD FDA UDI
GMDN Term
Orthopaedic surgical procedure kit, non-medicated, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 1.6 Millimeter FDA UDI

Category: Orthopaedic surgical procedure kit, non-medicated, single-use

GEO Bone Screw System by Gramercy Extremity Orthopedics, Llc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic surgical procedure kit, non-medicated, single-use.

Cleared under the same submission

K161904 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Gramercy Extremity Orthopedics, Llc.

Sources (1)

  • FDA UDI 76ece1fa-6bc7-4f31-a335-ba46370811ab 37 fields · synced Jun 8, 2026