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Tie-In

FDA UDI

Class II (US FDA UDI)

by Wright Medical Technology, Inc.

Identity

Trade Name
TIE-IN FDA UDI
Generic Name
Total wrist carpal articulation prosthesis FDA UDI
Model / Reference
8563003 FDA UDI

Identifiers

Catalog Number
8563003 FDA UDI
Primary DI / UDI-DI
00840420121844 FDA UDI
FDA Product Code
KYI FDA UDI
GMDN Term
Total wrist carpal articulation prosthesis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3770 FDA UDI
Commercial Distribution
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

Yes

FDA UDI

Category: Total wrist carpal articulation prosthesis

Tie-In by Wright Medical Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Total wrist carpal articulation prosthesis.

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 45c58db5-39b7-4caa-a883-ee8d2350fed1 35 fields · synced Jun 8, 2026