Identity
- Trade Name
- QUANTUM FDA UDI
- Generic Name
- Orthopaedic instrument surgical connector FDA UDI
- Device Name
- QUANTUM Tibial Implant Guide FDA UDI
- Model / Reference
- M05 00731 FDA UDI
- Description
- QUANTUM Tibial Implant Guide FDA UDI
Identifiers
- Catalog Number
- M05 00731 FDA UDI
- Primary DI / UDI-DI
- 03701337605520 FDA UDI
- 510(k) Number
- K191380 FDA UDI
- FDA Product Code
- FZX FDA UDI
- GMDN Term
- Orthopaedic instrument surgical connector FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
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
Dimensions & Sizes
- Size
- Length — 28 Millimeter FDA UDIHeight — 31.8 Millimeter FDA UDI
Category: Orthopaedic instrument surgical connector
Quantum by In2bones — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic instrument surgical connector.
- Surgical Instrument — Jeil Medical Corporation · Class I
- Maxim® Instrumentation — Biomet Orthopedics, Inc. · Class I
- KINCISE™ System Acetabular Cup Extraction SST Head 28mm — Spierings Orthopaedics B.V. · Class I
- Solstice Occipito-Cervico-Thoracic System — Life Spine, Inc. · Class II
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class I
- Pilot Spinal System — Life Spine, Inc. · Class II
- MIS Curved Rod, Ø5.5 x 85mm — Captiva Spine · Class II
- Ti-Diagon — CAMBER SPINE TECHNOLOGIES · Class I
Cleared under the same submission
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
- In2bones
Sources (1)
- FDA UDI 5cc766bc-96c5-4672-bd01-e1aaa6539d1e 37 fields · synced May 30, 2026