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Aequalis™ Adjustable Reversed

FDA UDI

Class II (US FDA UDI)

by Tornier, Inc.

Identity

Trade Name
Aequalis™ Adjustable Reversed FDA UDI
Generic Name
Humeral head spacer FDA UDI
Model / Reference
6501715 FDA UDI

Identifiers

Catalog Number
6501715 FDA UDI
Primary DI / UDI-DI
00846832060351 FDA UDI
FDA Product Code
KWT FDA UDI
HSD FDA UDI
KWS FDA UDI
GMDN Term
Humeral head spacer FDA UDI

Classification

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 17 Millimeter FDA UDI
Length — 15 Millimeter FDA UDI

Category: Humeral head spacer

Aequalis™ Adjustable Reversed by Tornier, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Humeral head spacer.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tornier, Inc.

Sources (1)

  • FDA UDI 1abf2062-67db-4d86-a64a-11b9b8dc9506 35 fields · synced May 30, 2026