Identity
- Trade Name
- Agilon FDA UDI
- Generic Name
- Synthetic bone graft FDA UDI
- Device Name
- Agilon Collagen Enhanced Bone Graft Substitute Strip, Large FDA UDI
- Model / Reference
- 020-AGS FDA UDI
- Description
- Agilon Collagen Enhanced Bone Graft Substitute Strip, Large FDA UDI
Identifiers
- Catalog Number
- 020-AGS FDA UDI
- Primary DI / UDI-DI
- 00812593020392 FDA UDI
- 510(k) Number
- K193487 FDA UDI
- FDA Product Code
- MQV FDA UDI
- GMDN Term
- Synthetic bone graft FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3045 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Synthetic bone graft
Agilon by Biogennix, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K193487 also covers:
- Agilon — Biogennix, LLC
- Agilon Strip — Biogennix, LLC
- Agilon Strip — Biogennix, LLC
- Agilon Strip — Biogennix, LLC
- Agilon Strip — Biogennix, LLC
- DirectCell Advanced Bone Grafting System — Biogennix, LLC
- DirectCell Advanced Bone Grafting System — Biogennix, LLC
- NeoForm Matrix — Biogennix, LLC
- NeoForm Matrix — Biogennix, LLC
- NeoForm Matrix — Biogennix, LLC
- NeoForm Matrix — Biogennix, LLC
- NeoForm Matrix — Biogennix, 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 |
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Manufacturer
- Manufacturer
- Biogennix, LLC
Sources (1)
- FDA UDI 592dff11-9d34-4262-8702-feed86359b88 36 fields · synced Jun 8, 2026