Baby Gorilla/Gorilla Plating System

FDA UDI

Class I (US FDA UDI)

by Paragon 28

Identity

Trade Name: Baby Gorilla/Gorilla Plating System FDA UDI
Generic Name: Bone approximation clamp FDA UDI
Device Name: Sharp Tip Bone Reduction Clamp FDA UDI
Model / Reference: P99-150-0013 FDA UDI
Description: Sharp Tip Bone Reduction Clamp FDA UDI

Identifiers

Catalog Number: P99-150-0013 FDA UDI
Primary DI / UDI-DI: 00889795040794 FDA UDI
FDA Product Code: HTD FDA UDI
GMDN Term: Bone approximation clamp 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Bone approximation clamp

Baby Gorilla/Gorilla Plating System by Paragon 28 — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone approximation clamp.

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PERI-LOC VLP — Smith & Nephew, Inc. · Class II
LEGION — Smith & Nephew, Inc. · Class I
Bone Clamp — Koros USA, Inc. · Class I
PROFIX — Smith & Nephew, Inc. · Class II
Sklar® — Sklar Corporation · Class I
BOSS Instruments — Boss Instruments, Ltd. · Class I
Symmetry Martin — SYMMETRY SURGICAL INC. · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Paragon 28

Sources (1)

FDA UDI 51615162-375d-44a7-9067-f04a22ee4dd5 34 fields · synced May 30, 2026