Identity
- Trade Name
- ES™ RETROGRADE FEMORAL NAIL 10mm x 36cm FDA UDI
- Generic Name
- Femur nail, non-sterile FDA UDI
- Model / Reference
- 1390-036 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848665034424 FDA UDI
- 510(k) Number
- K191598 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Femur nail, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3020 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
Category: Femur nail, non-sterile
ES™ RETROGRADE FEMORAL NAIL 10mm x 36cm by Advanced Orthopaedic Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Femur nail, non-sterile.
- Flow-Nail™ — Flow-Fx, LLC · Class II
- OIC Intramedullary Nail System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II
- AIM™FEMORAL NAIL — Biomet Orthopedics, Inc. · Class II
- Syntec Femoral Nail System — Syntec Scientific Corp. · Class II
- A.R.T.™FEMORAL NAIL — Biomet Orthopedics, Inc. · Class II
- Syntec Femoral Nail System — Syntec Scientific Corp. · Class II
- Syntec Femoral Nail System — Syntec Scientific Corp. · Class II
- Syntec Femoral Nail System — Syntec Scientific Corp. · Class II
Cleared under the same submission
K191598 also covers:
- ES™ RETROGRADE FEMORAL NAIL 10mm x 30cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- ES™ RETROGRADE FEMORAL NAIL 10mm x 32cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- ES™ RETROGRADE FEMORAL NAIL 10mm x 34cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- ES™ RETROGRADE FEMORAL NAIL 10mm x 38cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- ES™ RETROGRADE FEMORAL NAIL 10mm x 40cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- ES™ RETROGRADE FEMORAL NAIL 11mm x 30cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- ES™ RETROGRADE FEMORAL NAIL 11mm x 32cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- ES™ RETROGRADE FEMORAL NAIL 11mm x 34cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- ES™ RETROGRADE FEMORAL NAIL 11mm x 36cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- ES™ RETROGRADE FEMORAL NAIL 11mm x 38cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- ES™ RETROGRADE FEMORAL NAIL 11mm x 40cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- ES™ RETROGRADE FEMORAL NAIL 12mm x 30cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
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 |
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Manufacturer
- Manufacturer
- Advanced Orthopaedic Solutions, Inc.
Sources (1)
- FDA UDI 084b2ee7-3f0b-45cc-9733-6f9c5f3a8246 33 fields · synced Jun 8, 2026