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RFS™ Screw

FDA UDI

Class II (US FDA UDI)

by Bioretec Oy

Identity

Trade Name
RFS™ Screw FDA UDI
Generic Name
Bioabsorbable orthopaedic bone screw FDA UDI
Device Name
RFS™ Screw 4.5 x 40 mm FDA UDI
Model / Reference
RFS-S4540 FDA UDI
Description
RFS™ Screw 4.5 x 40 mm FDA UDI

Identifiers

Catalog Number
RFS-S4540 FDA UDI
Primary DI / UDI-DI
E302RFSS45409 FDA UDI
510(k) Number
K081392 FDA UDI
FDA Product Code
HWC FDA UDI
GMDN Term
Bioabsorbable orthopaedic bone screw FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3040 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

Dimensions & Sizes

Size
Length — 40 Millimeter FDA UDI
Width — 4.5 Millimeter FDA UDI

RFS™ Screw by Bioretec Oy — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K081392 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bioretec Oy

Sources (1)

  • FDA UDI 5aceebd7-227a-4dc0-b613-d33c8c9a142b 39 fields · synced Jun 1, 2026