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Ijs

FDA UDI

Class II (US FDA UDI)

by Skeletal Dynamics L.l.c.

Identity

Trade Name
IJS FDA UDI
Generic Name
Orthopaedic bone screw (non-sliding) FDA UDI
Device Name
Screw, Polyaxial Non Locking, 3.5mm x 38mm, Ti FDA UDI
Model / Reference
Screw, Polyaxial Non Locking, 3.5mm x 38mm, Ti FDA UDI
Description
Screw, Polyaxial Non Locking, 3.5mm x 38mm, Ti FDA UDI

Identifiers

Catalog Number
PANL-35380-IJS FDA UDI
Primary DI / UDI-DI
00841506105024 FDA UDI
FDA Product Code
LXT FDA UDI
OZI FDA UDI
GMDN Term
Orthopaedic bone screw (non-sliding) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3030 FDA UDI
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

Category: Orthopaedic bone screw (non-sliding)

Ijs by Skeletal Dynamics L.l.c. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Skeletal Dynamics L.l.c.

Sources (1)

  • FDA UDI daa41414-d77e-4bf2-85c6-6d5430e98218 35 fields · synced Jun 1, 2026