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Grappler R3FLEX Stabilization System

FDA UDI

Class II (US FDA UDI)

by Paragon 28

Identity

Trade Name
Grappler R3FLEX Stabilization System FDA UDI
Generic Name
Orthopaedic surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
Grappler R3FLEX Single Implant Kit FDA UDI
Model / Reference
P82-001-1237-SK FDA UDI
Description
Grappler R3FLEX Single Implant Kit FDA UDI

Identifiers

Catalog Number
P82-001-1237-SK FDA UDI
Primary DI / UDI-DI
00889795128140 FDA UDI
510(k) Number
K240594 FDA UDI
FDA Product Code
MBI FDA UDI
GMDN Term
Orthopaedic surgical procedure kit, non-medicated, single-use 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

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

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

Grappler R3FLEX Stabilization System by Paragon 28 — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Paragon 28

Sources (1)

  • FDA UDI 21c48bf9-c1c1-4e1b-bb9e-32892c23964a 35 fields · synced May 30, 2026