Identity
- Trade Name
- Envoy Percutaneous Implant Guide System FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Device Name
- Jack Screw FDA UDI
- Model / Reference
- 28-01-03 FDA UDI
- Description
- Jack Screw FDA UDI
Identifiers
- Catalog Number
- 828-0003 FDA UDI
- Primary DI / UDI-DI
- M7408280003 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
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
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
MR Unsafe FDA UDI
Category: Orthopaedic prosthesis implantation positioning instrument, reusable
Envoy Percutaneous Implant Guide System by Spineology Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic prosthesis implantation positioning instrument, reusable.
- DJO SURGICAL — DJO, LLC · Class I
- ALEUTIAN Interbody Systems — K2M, INC. · Class I
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class I
- A/P Sizer, Klassic ONE — TOTAL JOINT ORTHOPEDICS, INC. · Class I
- ARCADIUS XP C — AESCULAP, INC. · Class I
- LUCENT — SPINAL ELEMENTS, INC. · Class I
- U-KneeTec — CORIN LTD · Class II
- NCB® — Zimmer, Inc. · Class II
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
- Spineology Inc.
Sources (1)
- FDA UDI 60567f9b-1697-4eb3-bc97-87b4e86a36bd 35 fields · synced Jun 1, 2026