Axsos

FDA UDI

Class II (US FDA UDI)

by Stryker Corp.

Identity

Trade Name: AXSOS FDA UDI
Generic Name: Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Device Name: Locking Compression Plate Broad FDA UDI
Model / Reference: 627568 FDA UDI
Description: Locking Compression Plate Broad FDA UDI

Identifiers

Catalog Number: 627568 FDA UDI
Primary DI / UDI-DI: 07613327174960 FDA UDI
510(k) Number: K162439 FDA UDI
K222381 FDA UDI
FDA Product Code: HRS FDA UDI
HWC FDA UDI
GMDN Term: Orthopaedic fixation plate, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3030 FDA UDI
888.3040 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Length — 155.0 Millimeter FDA UDI

Category: Orthopaedic fixation plate, non-bioabsorbable

Axsos by Stryker Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Orthopaedic fixation plate, non-bioabsorbable.

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osteo-WEDGE2 12 Degree Angulated Bone Plate Implant, Large — Gramedica · Class II

Cleared under the same submission

K162439 also covers:

K222381 also covers:

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 II	Pending data

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Manufacturer

Manufacturer: Stryker Corp.

Sources (1)

FDA UDI f64c125a-da1e-412e-be85-541510f5af75 36 fields · synced Jun 8, 2026