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AOS CAPTURED CORTICAL SCREW 5.0mm x 105mm

FDA UDI

Class II (US FDA UDI)

by Advanced Orthopaedic Solutions, Inc.

Identity

Trade Name
AOS CAPTURED CORTICAL SCREW 5.0mm x 105mm FDA UDI
Generic Name
Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
Model / Reference
8001-105 FDA UDI

Identifiers

Primary DI / UDI-DI
00848665019315 FDA UDI
510(k) Number
K012190 FDA UDI
K021008 FDA UDI
K070444 FDA UDI
K123569 FDA UDI
K132005 FDA UDI
FDA Product Code
HSB FDA UDI
GMDN Term
Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3020 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic bone screw, non-bioabsorbable, non-sterile

AOS CAPTURED CORTICAL SCREW 5.0mm x 105mm by Advanced Orthopaedic Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic bone screw, non-bioabsorbable, non-sterile.

Cleared under the same submission

K012190 also covers:

K021008 also covers:

K070444 also covers:

K123569 also covers:

K132005 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 9537e7e7-8ee7-458d-b34d-d944f99a28fa 33 fields · synced Jun 8, 2026