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REDEMPTION Beaming System

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K221342

by Vilex, Inc.

Identity

Trade Name
REDEMPTION Beaming System FDA UDI
Generic Name
Orthopaedic bone screw (non-sliding) FDA UDI
Device Name
Screw, Compression Full Thread 6.5x60mm FDA UDI
Model / Reference
RFT65-60T-15 FDA UDI
Description
Screw, Compression Full Thread 6.5x60mm FDA UDI

Identifiers

Catalog Number
RFT65-60T-15 FDA UDI
Primary DI / UDI-DI
00841731131737 FDA UDI
510(k) Number
K221342 FDA 510(k)FDA UDI
FDA Product Code
HWC FDA 510(k)FDA UDI
GMDN Term
Orthopaedic bone screw (non-sliding) FDA UDI

Classification

Device Class
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 888.3040 FDA 510(k)
Regulation Number
888.3040 FDA 510(k)FDA UDI
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
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

Yes

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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

REDEMPTION Beaming System by Vilex, Inc. — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Vilex, Inc.
FDA Applicant
Vilex, LLC

Sources (2)

  • FDA 510(k) K221342 24 fields · synced Jun 18, 2026
  • FDA UDI e40ee3d3-bb2d-4276-b92e-63d9203a1a20 35 fields · synced May 27, 2026