← Back to catalogue

AOS CANCELLOUS SCREW 5.0mm x 100mm

FDA UDI

Class II (US FDA UDI)

by Advanced Orthopaedic Solutions, Inc.

Identity

Trade Name
AOS CANCELLOUS SCREW 5.0mm x 100mm FDA UDI
Generic Name
Orthopaedic bone screw, non-bioabsorbable, sterile FDA UDI
Model / Reference
S8022-100 FDA UDI

Identifiers

Primary DI / UDI-DI
00848665008470 FDA UDI
510(k) Number
K050241 FDA UDI
FDA Product Code
HSB FDA UDI
GMDN Term
Orthopaedic bone screw, non-bioabsorbable, sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3020 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

AOS CANCELLOUS SCREW 5.0mm x 100mm by Advanced Orthopaedic Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K050241 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Advanced Orthopaedic Solutions, Inc.

Sources (1)

  • FDA UDI 7fb5e708-4e36-4e5f-a9c7-56f6f6ea3f00 34 fields · synced May 31, 2026