Identity
- Trade Name
- ZAVATION FDA UDI
- Generic Name
- Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, non-sterile FDA UDI
- Device Name
- SI Screw, 12.5mm x 40mm FDA UDI
- Model / Reference
- 730-12540 FDA UDI
- Description
- SI Screw, 12.5mm x 40mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00842166172968 FDA UDI
- 510(k) Number
- K173752 FDA UDI
- FDA Product Code
- OUR FDA UDIHWC FDA UDI
- GMDN Term
- Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, non-sterile 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 implant, uncoated, non-sterile
Zavation by Zavation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, non-sterile.
- Sacroiliac Joint Fusion System — Genesys Orthopedics Systems LLC · Class II
- ZESPIN SI Joint Fusion System — Aegis Spine, Inc. · Class II
- CATAMARAN™ SIJ Fusion System — Tenon Medical · Class II
- Sacroiliac Joint Fusion System — Genesys Orthopedics Systems LLC · Class II
- Sacroiliac Joint Fusion System — Genesys Orthopedics Systems LLC · Class II
- Orion Sacroiliac Joint Fusion System — Pantheon Spinal LLC · Class II
- Sacroiliac Joint Fusion System — Genesys Orthopedics Systems LLC · Class II
- ZESPIN SI Joint Fusion System — Aegis Spine, Inc. · Class II
Cleared under the same submission
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
- Zavation
Sources (1)
- FDA UDI 95926193-8927-47d9-a51b-0140ee4f4431 35 fields · synced May 30, 2026