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Signature™ Comprehensive®

FDA UDI

Class II (US FDA UDI)

by Orthosoft Inc

Identity

Trade Name
Signature™ Comprehensive® FDA UDI
Generic Name
Orthopaedic prosthesis implantation positioning instrument, single-use FDA UDI
Model / Reference
20-8090-009-01 FDA UDI

Identifiers

Catalog Number
20-8090-009-01 FDA UDI
Primary DI / UDI-DI
00887868554391 FDA UDI
510(k) Number
K232425 FDA UDI
FDA Product Code
KWS FDA UDI
HSD FDA UDI
MBF FDA UDI
KWT FDA UDI
PHX FDA UDI
QHE FDA UDI
GMDN Term
Orthopaedic prosthesis implantation positioning instrument, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3660 FDA UDI
888.3690 FDA UDI
888.3670 FDA UDI
888.3650 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

Yes

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 prosthesis implantation positioning instrument, single-use

A comprehensive hand-held surgical instrument designed to aid in the navigation and placement of orthopaedic prosthesis or other instruments during implantation.

Similar devices

Also classified as Orthopaedic prosthesis implantation positioning instrument, single-use.

Cleared under the same submission

K232425 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Orthosoft Inc

Sources (1)

  • FDA UDI 8d7e1c34-d93b-4f04-b150-037a92471679 35 fields · synced Jul 17, 2026