Identity
- Trade Name
- Simpact FDA UDI
- Generic Name
- Sacroiliac joint transarticular fixation/arthrodesis implantation kit FDA UDI
- Device Name
- 300mm x 2.4mm Steinmann Pin, Threaded-Blunt, 17.4 SS FDA UDI
- Model / Reference
- 152-166 FDA UDI
- Description
- 300mm x 2.4mm Steinmann Pin, Threaded-Blunt, 17.4 SS FDA UDI
Identifiers
- Catalog Number
- 152-166 FDA UDI
- Primary DI / UDI-DI
- 00190837089191 FDA UDI
- 510(k) Number
- K180749 FDA UDI
- FDA Product Code
- OUR FDA UDI
- GMDN Term
- Sacroiliac joint transarticular fixation/arthrodesis implantation kit 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
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Sacroiliac joint transarticular fixation/arthrodesis implantation kit
Simpact by Life Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 57baf53b-3dc0-4a00-bc15-d309a4fdc8fe 35 fields · synced May 31, 2026