Identity
- Trade Name
- Simpact FDA UDI
- Generic Name
- Interspinous spinal fixation implant FDA UDI
- Device Name
- SI Screw, Lag, 8mm x 40mm FDA UDI
- Model / Reference
- 152-08-640 FDA UDI
- Description
- SI Screw, Lag, 8mm x 40mm FDA UDI
Identifiers
- Catalog Number
- 152-08-640 FDA UDI
- Primary DI / UDI-DI
- 00190837101534 FDA UDI
- 510(k) Number
- K180749 FDA UDI
- FDA Product Code
- OUR FDA UDI
- GMDN Term
- Interspinous spinal fixation implant 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
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Interspinous spinal fixation implant
Simpact by Life Spine, Inc. — 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
- InFill V2 Lateral PE — PINNACLE SPINE GROUP, LLC · Class II
Cleared under the same submission
K180749 also covers:
- Simpact — Life Spine, Inc.
- Simpact — Life Spine, Inc.
- Simpact — Life Spine, Inc.
- Simpact — Life Spine, Inc.
- Simpact — Life Spine, Inc.
- Simpact — Life Spine, Inc.
- Simpact — Life Spine, Inc.
- Simpact — Life Spine, Inc.
- Simpact — Life Spine, Inc.
- Simpact — Life Spine, Inc.
- Simpact — Life Spine, Inc.
- Simpact — Life Spine, 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
- Life Spine, Inc.
Sources (1)
- FDA UDI 6eb9e045-0ce6-42b5-b4c9-a34c903735dc 35 fields · synced Jun 1, 2026