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AOS CAPTURED CANCELLOUS SCREW, FULLY THREADED 6.5mm x 80mm

FDA UDI

Class II (US FDA UDI)

by Advanced Orthopaedic Solutions, Inc.

Identity

Trade Name
AOS CAPTURED CANCELLOUS SCREW, FULLY THREADED 6.5mm x 80mm FDA UDI
Generic Name
Orthopaedic bone screw, non-bioabsorbable, sterile FDA UDI
Model / Reference
S8065-080 FDA UDI

Identifiers

Primary DI / UDI-DI
00848665023169 FDA UDI
510(k) Number
K141228 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 CAPTURED CANCELLOUS SCREW, FULLY THREADED 6.5mm x 80mm by Advanced Orthopaedic Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID

Cleared under the same submission

K141228 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Advanced Orthopaedic Solutions, Inc.

Sources (1)

  • FDA UDI 318ababa-9be5-4808-a06a-74f4e901f085 34 fields · synced Jun 8, 2026