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Orthospec

FDA UDI

Class III (US FDA UDI)

by Medispec, Ltd.

Identity

Trade Name
Orthospec FDA UDI
Generic Name
Spark-gap orthopaedic extracorporeal shock wave therapy system FDA UDI
Device Name
Orthospec is based on shock wave therapy method and is intended to apply shock waves to the heel tissue of patients who have Proximal Plantar Fasciitis and who have failed previous conservative therapies. FDA UDI
Model / Reference
OR-3-A999u FDA UDI
Description
Orthospec is based on shock wave therapy method and is intended to apply shock waves to the heel tissue of patients who have Proximal Plantar Fasciitis and who have failed previous conservative therapies. FDA UDI

Identifiers

Primary DI / UDI-DI
07290016498417 FDA UDI
PMA Number
P040026 FDA UDI
FDA Product Code
NBN FDA UDI
GMDN Term
Spark-gap orthopaedic extracorporeal shock wave therapy system FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Spark-gap orthopaedic extracorporeal shock wave therapy system

Orthospec by Medispec, Ltd. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spark-gap orthopaedic extracorporeal shock wave therapy system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medispec, Ltd.

Sources (1)

  • FDA UDI 1ff08c82-3657-4495-9775-aa509907937e 34 fields · synced May 30, 2026