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TransFasten - LSF (Lateral Sacroiliac Fusion System)
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- TransFasten - LSF (Lateral Sacroiliac Fusion System) FDA UDI
- Generic Name
- Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated FDA UDI
- Device Name
- Sacroiliac Immobilization Device - 9mm (D) x 35mm (L) FDA UDI
- Model / Reference
- 10-1-1035 FDA UDI
- Description
- Sacroiliac Immobilization Device - 9mm (D) x 35mm (L) FDA UDI
Identifiers
- Primary DI / UDI-DI
- M73910110350 FDA UDI
- 510(k) Number
- K170475 FDA UDI
- FDA Product Code
- OUR FDA UDIHWC FDA UDI
- GMDN Term
- Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated 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
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: Sacroiliac joint transarticular fixation/arthrodesis implant, uncoatedSacroiliac joint intra-articular arthrodesis implant
TransFasten - LSF (Lateral Sacroiliac Fusion System) by Captiva Spine — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Sacroiliac joint intra-articular arthrodesis implant.
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- Simmetry — Sivantage · Class II
- Liberty SI — Spinal Simplicity, LLC · Class II
- Simmetry — Sivantage · Class II
- Simmetry — Sivantage · Class II
- Simmetry — Sivantage · Class II
Cleared under the same submission
K170475 also covers:
- TransFasten - LSF (Lateral Sacroiliac Fusion System) — Captiva Spine
- TransFasten - LSF (Lateral Sacroiliac Fusion System) — Captiva Spine
- TransFasten - LSF (Lateral Sacroiliac Fusion System) — Captiva Spine
- TransFasten - LSF (Lateral Sacroiliac Fusion System) — Captiva Spine
- TransFasten - LSF (Lateral Sacroiliac Fusion System) — Captiva Spine
- TransFasten - LSF (Lateral Sacroiliac Fusion System) — Captiva Spine
- TransFasten - LSF (Lateral Sacroiliac Fusion System) — Captiva Spine
- TransFasten - LSF (Lateral Sacroiliac Fusion System) — Captiva Spine
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Captiva Spine
Sources (1)
- FDA UDI d0a769e1-8207-4cd3-856b-d2bc8308c0a1 35 fields · synced Jun 1, 2026