Identity
- Trade Name
- Harmony FDA UDI
- Generic Name
- Intraoperative orthopaedic bone pin/screw, single-use FDA UDI
- Device Name
- MIS 3.2MM X 30MM RIMMED PIN STERILE FDA UDI
- Model / Reference
- 74016464 FDA UDI
- Description
- MIS 3.2MM X 30MM RIMMED PIN STERILE FDA UDI
Identifiers
- Catalog Number
- 74016464 FDA UDI
- Primary DI / UDI-DI
- 00885556691977 FDA UDI
- 510(k) Number
- K113038 FDA UDI
- FDA Product Code
- HSX FDA UDI
- GMDN Term
- Intraoperative orthopaedic bone pin/screw, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3520 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
No
FDA UDI
Category: Intraoperative orthopaedic bone pin/screw, single-use
Harmony by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K113038 also covers:
- ACCURIS — Smith & Nephew, Inc.
- ACCURIS — Smith & Nephew, Inc.
- ACCURIS — Smith & Nephew, Inc.
- ACCURIS — Smith & Nephew, Inc.
- ACCURIS — Smith & Nephew, Inc.
- ACCURIS — Smith & Nephew, Inc.
- ACCURIS — Smith & Nephew, Inc.
- ACCURIS — Smith & Nephew, Inc.
- ACCURIS — Smith & Nephew, Inc.
- ACCURIS — Smith & Nephew, Inc.
- ACCURIS — Smith & Nephew, Inc.
- ACCURIS — Smith & Nephew, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI ae9e1f35-cd5b-45d0-8658-225780a63bed 36 fields · synced Jun 6, 2026