Identity
- Trade Name
- DJO SURGICAL FDA UDI
- Generic Name
- Surgical implant template, reusable FDA UDI
- Device Name
- TRIAL, DISTAL STEM 15X180 KEYSTONE FDA UDI
- Model / Reference
- 803-06-017 FDA UDI
- Description
- TRIAL, DISTAL STEM 15X180 KEYSTONE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888912093897 FDA UDI
- FDA Product Code
- HWT FDA UDI
- GMDN Term
- Surgical implant template, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
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: Surgical implant template, reusable
Djo Surgical by Djo, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical implant template, reusable.
- Newclip Instruments — NEWCLIP TECHNICS · Class I
- Titan Reverse Shoulder System — Smith & Nephew, Inc. · Class I
- Legion — Smith & Nephew, Inc. · Class II
- LIGAFIX® — S.B.M. SAS · Class I
- EVOS — Smith & Nephew, Inc. · Class I
- Tranquil-C™ — NEXUS SPINE, L.L.C. · Class I
- VFT — Ldr Spine USA · Class II
- Tranquil-C™ — NEXUS SPINE, L.L.C. · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Djo, Llc
Sources (1)
- FDA UDI 23afcf7d-906f-4552-92e1-af5c49899ffc 33 fields · synced May 31, 2026