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Ibis

FDA UDI

Class II (US FDA UDI)

by Ortho Development Corp.

Identity

Trade Name
Ibis FDA UDI
Generic Name
Bone-screw internal spinal fixation system rod FDA UDI
Device Name
Diameter 5.5 mm x 85 mm Curved Bulleted Rod Ti FDA UDI
Model / Reference
158-0085-03 FDA UDI
Description
Diameter 5.5 mm x 85 mm Curved Bulleted Rod Ti FDA UDI

Identifiers

Primary DI / UDI-DI
00822409024285 FDA UDI
510(k) Number
K142146 FDA UDI
FDA Product Code
MNI FDA UDI
MNH FDA UDI
NKB FDA UDI
GMDN Term
Bone-screw internal spinal fixation system rod FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3070 FDA UDI
Commercial Distribution
Not 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

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Length — 85 Millimeter FDA UDI
Outer Diameter — 5.5 Millimeter FDA UDI

Ibis by Ortho Development Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K142146 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ortho Development Corp.

Sources (1)

  • FDA UDI bdeb1785-b6c5-42a0-ba8a-bb790e447f72 37 fields · synced May 31, 2026