Identity
- Trade Name
- Epiphany FDA UDI
- Generic Name
- Nerve/vessel retractor FDA UDI
- Device Name
- Nerve root retractor FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Nerve root retractor FDA UDI
Identifiers
- Catalog Number
- 1021-0000 FDA UDI
- Primary DI / UDI-DI
- B528102100000 FDA UDI
- 510(k) Number
- K113781 FDA UDI
- FDA Product Code
- MAX FDA UDI
- GMDN Term
- Nerve/vessel retractor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Nerve/vessel retractor
Epiphany by Pantheon Spinal LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nerve/vessel retractor.
- Ambler Surgical — Ambler Surgical, LLC · Class I
- BOSS Instruments — Boss Instruments, Ltd. · Class I
- Life Instruments — Life Instrument Corporation · Class I
- Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class I
- JACOBSON SHEPARDS HOOK PROBE — SONTEC INSTRUMENTS, INC. · Class I
- Avalign — AVALIGN TECHNOLOGIES, Inc. · Class I
- Integra® Ruggles®-Redmond™ — Integra LifeSciences Production Corporation · Class I
- RAVINE Lateral Access System — K2M, INC. · Class I
Cleared under the same submission
K113781 also covers:
- EPIPHANY — Pantheon Spinal LLC
- EPIPHANY — Pantheon Spinal LLC
- EPIPHANY — Pantheon Spinal LLC
- EPIPHANY — Pantheon Spinal LLC
- EPIPHANY — Pantheon Spinal LLC
- EPIPHANY — Pantheon Spinal LLC
- EPIPHANY — Pantheon Spinal LLC
- EPIPHANY — Pantheon Spinal LLC
- EPIPHANY — Pantheon Spinal LLC
- EPIPHANY — Pantheon Spinal LLC
- EPIPHANY — Pantheon Spinal LLC
- EPIPHANY — Pantheon Spinal LLC
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
- Pantheon Spinal LLC
Sources (1)
- FDA UDI d0c02841-a44a-4a5b-87c9-0bab5d66efc5 36 fields · synced Jun 1, 2026