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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
6501300 FDA UDI

Identifiers

Catalog Number
6501300 FDA UDI
Primary DI / UDI-DI
00846832060245 FDA UDI
FDA Product Code
HSD FDA UDI
KWS FDA UDI
KWT FDA UDI
GMDN Term
Humeral head spacer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3690 FDA UDI
888.3660 FDA UDI
888.3650 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 — 13 Millimeter FDA UDI
Length — 100 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 08427a8a-fa36-4030-beab-f8c3e940bbd6 35 fields · synced Jun 8, 2026