Identity
- Trade Name
- InFIll Lateral Lordotic FDA UDI
- Generic Name
- Interspinous spinal fixation implant FDA UDI
- Model / Reference
- 54-5012 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814729024786 FDA UDI
- 510(k) Number
- K121733 FDA UDI
- FDA Product Code
- MAX FDA UDI
- GMDN Term
- Interspinous spinal fixation implant 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
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Category: Interspinous spinal fixation implant
InFIll Lateral Lordotic by Pinnacle Spine Group, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Interspinous spinal fixation implant.
- Axle Interspinous Fusion System — Xtant Medical Holdings, Inc. · Class II
- Benefix™ Interspinous Fixation System — CG MedTech Co., Ltd. · Class II
- ASPEN MIS FUSION SYSTEM — BIOMET SPINE LLC · Class II
- Axle Interspinous Fusion System — Xtant Medical Holdings, Inc. · Class II
- Benefix™ Interspinous Fixation System — CG MedTech Co., Ltd. · Class II
- Benefix™ Interspinous Fixation System — CG MedTech Co., Ltd. · Class II
- Axle Interspinous Fusion System — Xtant Medical Holdings, Inc. · Class II
- InSpan® — SPINEFRONTIER, INC. · Class II
Cleared under the same submission
K121733 also covers:
- InFIll Lateral Lordotic — PINNACLE SPINE GROUP, LLC
- InFIll Lateral Lordotic — PINNACLE SPINE GROUP, LLC
- InFIll Lateral Lordotic — PINNACLE SPINE GROUP, LLC
- InFIll Lateral Lordotic — PINNACLE SPINE GROUP, LLC
- InFIll Lateral Lordotic — PINNACLE SPINE GROUP, LLC
- InFIll Lateral Lordotic — PINNACLE SPINE GROUP, LLC
- InFIll Lateral Lordotic — PINNACLE SPINE GROUP, LLC
- InFIll Lateral Lordotic — PINNACLE SPINE GROUP, LLC
- InFIll Lateral Lordotic — PINNACLE SPINE GROUP, LLC
- InFIll Lateral Lordotic — PINNACLE SPINE GROUP, LLC
- InFIll Lateral Lordotic — PINNACLE SPINE GROUP, LLC
- InFIll Lateral Lordotic — PINNACLE SPINE GROUP, 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
- Pinnacle Spine Group, Llc
Sources (1)
- FDA UDI f0efa949-191b-4a85-a56f-1650ca1068c6 33 fields · synced May 30, 2026