Identity
- Trade Name
- AEQUALIS™ PerFORM Reversed FDA UDI
- Generic Name
- Reverse shoulder prosthesis head FDA UDI
- Model / Reference
- DWJ023 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00846832061945 FDA UDI
- 510(k) Number
- K161742 FDA UDI
- FDA Product Code
- KWS FDA UDIPHX FDA UDI
- GMDN Term
- Reverse shoulder prosthesis head FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 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 — 39 Millimeter FDA UDI
Category: Reverse shoulder prosthesis head
AEQUALIS™ PerFORM Reversed by Tornier, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Reverse shoulder prosthesis head.
- Equinoxe — Exactech, Inc. · Class II
- Equinoxe — Exactech, Inc. · Class II
- SMR System — Limacorporate · Class II
- SMR Shoulder — Limacorporate · Class II
- JARVIS Glenoid Rerverse Shoulder Prosthesis — FOURNITURES HOSPITALIERES INDUSTRIE · Class II
- Trabecular Metal Reverse Plus™ — Zimmer, Inc. · Class II
- AGILON® XO glenosphere neutral incl. screw — implantcast GmbH · Class II
- Titan™ Reverse Shoulder System — Ascension Orthopedics, Inc. · Class II
Cleared under the same submission
K161742 also covers:
- AEQUALIS™ PerFORM Reversed — TORNIER, INC.
- AEQUALIS™ PerFORM Reversed — TORNIER, INC.
- AEQUALIS™ PerFORM Reversed — TORNIER, INC.
- AEQUALIS™ PerFORM Reversed — TORNIER, INC.
- AEQUALIS™ PerFORM Reversed — TORNIER, INC.
- AEQUALIS™ PerFORM Reversed — TORNIER, INC.
- AEQUALIS™ PerFORM Reversed — TORNIER, INC.
- AEQUALIS™ PerFORM Reversed — TORNIER, INC.
- AEQUALIS™ PerFORM Reversed — TORNIER, INC.
- AEQUALIS™ PerFORM Reversed — TORNIER, INC.
- AEQUALIS™ PerFORM Reversed — TORNIER, INC.
- AEQUALIS™ PerFORM Reversed — TORNIER, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Tornier, Inc.
Sources (1)
- FDA UDI cd8a58b6-c6ee-4b8e-9f05-abc51a8bd764 35 fields · synced May 30, 2026