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Prophecy Invision

FDA UDI

Class I (US FDA UDI)

by Wright Medical Technology, Inc.

Identity

Trade Name
PROPHECY INVISION FDA UDI
Generic Name
Osteotomy guide, reusable FDA UDI
Device Name
Talus Resection Guide FDA UDI
Model / Reference
PINV1000 FDA UDI
Description
Talus Resection Guide FDA UDI

Identifiers

Catalog Number
PINV1000 FDA UDI
Primary DI / UDI-DI
00889797068345 FDA UDI
FDA Product Code
FZX FDA UDI
GMDN Term
Osteotomy guide, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 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

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

Yes

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: Osteotomy guide, reusable

A comprehensive osteotomy guide for precision and accuracy in surgical procedures. The Prophecy Invision is a durable, reusable instrument designed to outline the desired cut-line and support mechanical guidance during joint arthroplasty and osteotomy surgeries.

Similar devices

Also classified as Osteotomy guide, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Wright Medical Technology, Inc.

Sources (1)

  • FDA UDI 97b07e0e-4c8f-4726-be1c-2d14e66754e9 35 fields · synced Jul 8, 2026