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Axon

FDA UDI

Class II (US FDA UDI)

by Synthes (u.s.a.) Lp

Identity

Trade Name
Axon FDA UDI
Generic Name
Spinal bone screw, non-bioabsorbable FDA UDI
Device Name
3.5MM TI CORTEX AXON(TM) SCREW 28MM THREAD LENGTH FDA UDI
Model / Reference
404.528 FDA UDI
Description
3.5MM TI CORTEX AXON(TM) SCREW 28MM THREAD LENGTH FDA UDI

Identifiers

Catalog Number
404528 FDA UDI
Primary DI / UDI-DI
10705034778938 FDA UDI
FDA Product Code
NKG FDA UDI
MNI FDA UDI
KWP FDA UDI
MNH FDA UDI
GMDN Term
Spinal bone screw, non-bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3075 FDA UDI
888.3070 FDA UDI
888.3050 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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Axon by Synthes (u.s.a.) Lp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Synthes (u.s.a.) Lp

Sources (1)

  • FDA UDI eefe130a-9b41-402c-b36d-51f961a1558c 36 fields · synced Jun 1, 2026