Identity
- Trade Name
- SImmetry Implant, 12.5mm x 45mm FDA UDI
- Generic Name
- Microbial water purification filter, non-sterilizable FDA UDI
- Model / Reference
- 10-P12545-01 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260636674938 FDA UDI
- 510(k) Number
- K151818 FDA UDI
- FDA Product Code
- OUR FDA UDI
- GMDN Term
- Microbial water purification filter, non-sterilizable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Microbial water purification filter, non-sterilizable
SImmetry Implant, 12.5mm x 45mm by Paradigm Spine, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K151818 also covers:
- SImmetry Implant, 10.5mm x 40mm — Paradigm Spine, LLC
- SImmetry Implant, 10.5mm x 45mm — Paradigm Spine, LLC
- SImmetry Implant, 10.5mm x 60mm — Paradigm Spine, LLC
- SImmetry Implant, 10.5mm x 65mm — Paradigm Spine, LLC
- SImmetry Implant, 10.5mm x 70mm — Paradigm Spine, LLC
- SImmetry Implant, 10.5mm x 95mm — Paradigm Spine, LLC
- SImmetry Implant, 12.5mm x 100mm — Paradigm Spine, LLC
- SImmetry Implant, 12.5mm x 50mm — Paradigm Spine, LLC
- SImmetry Implant, 12.5mm x 55mm — Paradigm Spine, LLC
- SImmetry Implant, 12.5mm x 60mm — Paradigm Spine, LLC
- SImmetry Implant, 12.5mm x 85mm — Paradigm Spine, LLC
- SImmetry Implant, 12.5mm x 90mm — Paradigm Spine, 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
- Paradigm Spine, LLC
Sources (1)
- FDA UDI db86993c-1974-4f2a-8283-6cf47715c093 33 fields · synced May 30, 2026