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Gpc

FDA UDI

Class II (US FDA UDI)

by Gpc Medical, Ltd.

Identity

Trade Name
GPC FDA UDI
Generic Name
Femoral neck fixation sliding bone screw FDA UDI
Device Name
Locking Bolt 3.9 mm - Titanium FDA UDI
Model / Reference
ILB39.48T FDA UDI
Description
Locking Bolt 3.9 mm - Titanium FDA UDI

Identifiers

Primary DI / UDI-DI
08905892039515 FDA UDI
510(k) Number
K203811 FDA UDI
FDA Product Code
HWC FDA UDI
GMDN Term
Femoral neck fixation sliding bone screw FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3040 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Femoral neck fixation sliding bone screw

Gpc by Gpc Medical, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Femoral neck fixation sliding bone screw.

Cleared under the same submission

K203811 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Gpc Medical, Ltd.

Sources (1)

  • FDA UDI d25445dd-cf96-4fc0-8252-650233bf56e4 35 fields · synced May 30, 2026