Identity
- Trade Name
- Faset FDA UDI
- Generic Name
- General internal orthopaedic fixation system implantation kit FDA UDI
- Device Name
- Implant Caddy Case for 5.5 FDA UDI
- Model / Reference
- A FDA UDI
- Description
- Implant Caddy Case for 5.5 FDA UDI
Identifiers
- Catalog Number
- FA.CS.0055 FDA UDI
- Primary DI / UDI-DI
- 08809401499626 FDA UDI
- 510(k) Number
- K180729 FDA UDI
- FDA Product Code
- MRW FDA UDI
- GMDN Term
- General internal orthopaedic fixation system implantation kit FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: General internal orthopaedic fixation system implantation kit
Faset by Dio Medical Co., Ltd. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General internal orthopaedic fixation system implantation kit.
- Matrixx System — NEXXT SPINE LLC · Class I
- Swedge Pedicle Screw Fixation System — SPINAL RESOURCES INC · Class II
- tangis — NVISION BIOMEDICAL TECHNOLOGIES, INC · Class I
- OsteoMed — Osteomed Corp. · Class II
- ACUMED — ACUMED LLC · Class I
- OsteoMed — Osteomed Corp. · Class II
- ALEUTIAN® Interbody Systems — K2M, INC. · Class II
- HONOUR™ Spacer System — NEXXT SPINE LLC · Class II
Cleared under the same submission
K180729 also covers:
- FaSet — Dio Medical Co., Ltd.
- FaSet — Dio Medical Co., Ltd.
- FaSet — Dio Medical Co., Ltd.
- FaSet — Dio Medical Co., Ltd.
- FaSet — Dio Medical Co., Ltd.
- FaSet — Dio Medical Co., Ltd.
- FaSet — Dio Medical Co., Ltd.
- Faset — Dio Medical Co., Ltd.
- Faset — Dio Medical Co., Ltd.
- Faset — Dio Medical Co., Ltd.
- Faset — Dio Medical Co., Ltd.
- Faset — Dio Medical Co., Ltd.
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 U | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dio Medical Co., Ltd.
Sources (1)
- FDA UDI 9280cd2b-4375-4c86-9c74-8097c24aa603 36 fields · synced Jun 8, 2026