Identity
- Trade Name
- Aequalis™ PerFORM+ FDA UDI
- Generic Name
- Coated shoulder humeral stem prosthesis FDA UDI
- Model / Reference
- DWK404RA25 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00846832061495 FDA UDI
- 510(k) Number
- K150583 FDA UDI
- FDA Product Code
- KWS FDA UDI
- GMDN Term
- Coated shoulder humeral stem prosthesis 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
- Angle — 25 degree FDA UDI
Category: Coated shoulder humeral stem prosthesis
Aequalis™ PerFORM+ by Tornier, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Coated shoulder humeral stem prosthesis.
- OsseoFit™ Stemless Shoulder — Zimmer, Inc. · Class II
- Comprehensive® Shoulder System — Biomet Orthopedics, Inc. · Class II
- Trabecular Metal® — Zimmer, Inc. · Class II
- Comprehensive SRS — Biomet Orthopedics, Inc. · Class II
- INHANCE — DEPUY (IRELAND) · Class II
- Trabecular Metal® — Zimmer, Inc. · Class II
- Compress® Device — Biomet Orthopedics, Inc. · Class II
- Comprehensive® SRS — Biomet Orthopedics, Inc. · Class II
Cleared under the same submission
K150583 also covers:
- Aequalis™ PerFORM+ — TORNIER, INC.
- Aequalis™ PerFORM+ — TORNIER, INC.
- Aequalis™ PerFORM+ — TORNIER, INC.
- Aequalis™ PerFORM+ — TORNIER, INC.
- Aequalis™ PerFORM+ — TORNIER, INC.
- Aequalis™ PerFORM+ — TORNIER, INC.
- Aequalis™ PerFORM+ — TORNIER, INC.
- Aequalis™ PerFORM+ — TORNIER, INC.
- Aequalis™ PerFORM+ — TORNIER, INC.
- Aequalis™ PerFORM+ — TORNIER, INC.
- Aequalis™ PerFORM+ — TORNIER, INC.
- Aequalis™ PerFORM+ — 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 fb7d5f6e-8340-47ea-90f1-cefa7386dbd0 35 fields · synced May 30, 2026