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Ibis

FDA UDI

Class II (US FDA UDI)

by Ortho Development Corp.

Identity

Trade Name
Ibis FDA UDI
Generic Name
Spinal bone screw, non-bioabsorbable FDA UDI
Device Name
Diameter 7.5 mm x 60 mm Cannulated Monoaxial Screw FDA UDI
Model / Reference
752-7560-41 FDA UDI
Description
Diameter 7.5 mm x 60 mm Cannulated Monoaxial Screw FDA UDI

Identifiers

Primary DI / UDI-DI
00822409029457 FDA UDI
510(k) Number
K142146 FDA UDI
FDA Product Code
MNI FDA UDI
NKB FDA UDI
MNH FDA UDI
GMDN Term
Spinal bone screw, non-bioabsorbable 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
Outer Diameter — 7.5 Millimeter FDA UDI
Length — 60 Millimeter FDA UDI

An orthopedic implantable device used for spinal fixation, specifically designed for pedicle screw placement. This implant is available in various types, including threaded rods and screw head adaptors, which provide stability to the spine during treatment.

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 01c73b2e-5cbc-41a6-9857-0182bbf7cc06 37 fields · synced Jun 29, 2026