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AOS ES™ TROCHANTERIC NAIL, LEFT 10mm x 33cm x 130°

FDA UDI

Class II (US FDA UDI)

by Advanced Orthopaedic Solutions, Inc.

Identity

Trade Name
AOS ES™ TROCHANTERIC NAIL, LEFT 10mm x 33cm x 130° FDA UDI
Generic Name
Femur intramedullary nail FDA UDI
Model / Reference
S1066-335 FDA UDI

Identifiers

Primary DI / UDI-DI
00848665004519 FDA UDI
510(k) Number
K103533 FDA UDI
FDA Product Code
HSB FDA UDI
GMDN Term
Femur intramedullary nail 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

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

AOS ES™ TROCHANTERIC NAIL, LEFT 10mm x 33cm x 130° by Advanced Orthopaedic Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID

Cleared under the same submission

K103533 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 e4fef149-00c6-415f-823f-1fda2fbf2e7b 34 fields · synced Jun 8, 2026