Otis-C Plus

FDA UDI

Class I (US FDA UDI)

by S.b.m

Identity

Trade Name: OTIS-C PLUS FDA UDI
Generic Name: Orthopaedic bone screw (non-sliding) FDA UDI
Device Name: Screw for temporary fixation of OTIS-C PLUS osteosynthesis plate for HTO. FDA UDI
Model / Reference: Round head temporary screw FDA UDI
Description: Screw for temporary fixation of OTIS-C PLUS osteosynthesis plate for HTO. FDA UDI

Identifiers

Catalog Number: EVO9069A45 FDA UDI
Primary DI / UDI-DI: 03760154001113 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Orthopaedic bone screw (non-sliding) FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 3.5 Millimeter FDA UDI

Category: Orthopaedic bone screw (non-sliding)

Otis-C Plus by S.b.m — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic bone screw (non-sliding).

EVOS — Smith & Nephew, Inc. · Class II
TriLeap Lower Extremity Anatomic Plating System — CROSSROADS EXTREMITY SYSTEMS LLC · Class II
Arthrex® — Arthrex, Inc. · Class II
Zavation — ZAVATION · Class II
STARDRIVE — Synthes GmbH · Class IIb
Arthrex® — Arthrex, Inc. · Class II
Cancellous Screw, Locking — I.T.S. GmbH · Class II
PANGEA — Stryker Corp. · Class II

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: S.b.m

Sources (1)

FDA UDI cb25dd3d-d3a8-4d63-aee9-c0986652b354 35 fields · synced May 30, 2026