Identity
- Trade Name
- Seitz Solution Unlar Head FDA UDI
- Generic Name
- Wrist ulna-head prosthesis FDA UDI
- Device Name
- 13.5x14mm Ulnar Head FDA UDI
- Model / Reference
- KCUH-1314 FDA UDI
- Description
- 13.5x14mm Ulnar Head FDA UDI
Identifiers
- Catalog Number
- KCUH-1314 FDA UDI
- Primary DI / UDI-DI
- B033KCUH1314 FDA UDI
- 510(k) Number
- K033930 FDA UDI
- FDA Product Code
- KXE FDA UDI
- GMDN Term
- Wrist ulna-head prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3810 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Wrist ulna-head prosthesis
Seitz Solution Unlar Head by Kapp Surgical Instrument, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wrist ulna-head prosthesis.
- BioMotion Cannulated 1st MPJ Hemi System — Smith & Nephew, Inc. · Class II
- First Choice Modular Ulnar Head Implant — Smith & Nephew, Inc. · Class II
- Ascension® First Choice® DRUJ System — Ascension Orthopedics, Inc. · Class II
- Ascension® First Choice® DRUJ System — Ascension Orthopedics, Inc. · Class II
- UHEAD — Stryker Corp. · Class II
- Ascension® First Choice® DRUJ System — Ascension Orthopedics, Inc. · Class II
- Ascension® First Choice® DRUJ System — Ascension Orthopedics, Inc. · Class II
- UHEAD — Stryker Corp. · Class II
Cleared under the same submission
K033930 also covers:
- Seitz Solution Unlar Head — Kapp Surgical Instrument, Inc.
- Seitz Solution Unlar Head — Kapp Surgical Instrument, Inc.
- Seitz Solution Unlar Head — Kapp Surgical Instrument, Inc.
- Seitz Solution Unlar Head — Kapp Surgical Instrument, Inc.
- Seitz Solution Unlar Head — Kapp Surgical Instrument, Inc.
- Seitz Solution Unlar Head — Kapp Surgical Instrument, Inc.
- Seitz Solution Unlar Head — Kapp Surgical Instrument, Inc.
- Seitz Solution Unlar Head — Kapp Surgical Instrument, Inc.
- Seitz Solution Unlar Head — Kapp Surgical Instrument, Inc.
- Seitz Solution Unlar Head — Kapp Surgical Instrument, Inc.
- Seitz Solution Unlar Head — Kapp Surgical Instrument, Inc.
- Seitz Solution Unlar Head — Kapp Surgical Instrument, 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
- Kapp Surgical Instrument, Inc.
Sources (1)
- FDA UDI d4590bc5-926e-4737-ab34-f51edb0d646e 35 fields · synced Jun 9, 2026