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WORKHORSE SCREW™, T10, NON-LOCKING, Ø3.5mm x 60mm

FDA UDI

Class II (US FDA UDI)

by Advanced Orthopaedic Solutions, Inc.

Identity

Trade Name
WORKHORSE SCREW™, T10, NON-LOCKING, Ø3.5mm x 60mm FDA UDI
Generic Name
Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
Model / Reference
8100-060 FDA UDI

Identifiers

Primary DI / UDI-DI
00848665037173 FDA UDI
510(k) Number
K152732 FDA UDI
K161913 FDA UDI
K181035 FDA UDI
K182466 FDA UDI
K202489 FDA UDI
FDA Product Code
HRS FDA UDI
HTN FDA UDI
HWC FDA UDI
GMDN Term
Orthopaedic bone screw, non-bioabsorbable, non-sterile 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

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

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

WORKHORSE SCREW™, T10, NON-LOCKING, Ø3.5mm x 60mm by Advanced Orthopaedic Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID

Similar devices

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

Cleared under the same submission

K152732 also covers:

K161913 also covers:

K181035 also covers:

K182466 also covers:

K202489 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 ceb11169-c4f7-471d-b361-89deccb1a191 34 fields · synced May 31, 2026