Identity
- Trade Name
- Savant Lumbar Interbody Fusion System FDA UDI
- Generic Name
- Orthopaedic implant impactor, reusable FDA UDI
- Device Name
- Slotted Mallet FDA UDI
- Model / Reference
- C445-210 FDA UDI
- Description
- Slotted Mallet FDA UDI
Identifiers
- Primary DI / UDI-DI
- B648C4452100 FDA UDI
- 510(k) Number
- K181589 FDA UDI
- FDA Product Code
- MAX FDA UDI
- GMDN Term
- Orthopaedic implant impactor, reusable 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
No
FDA UDI
Single Use
No
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: Orthopaedic implant impactor, reusable
Savant Lumbar Interbody Fusion System by Curiteva, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K181589 also covers:
- Savant Lumbar Interbody Fusion System — Curiteva, LLC
- Savant Lumbar Interbody Fusion System — Curiteva, LLC
- Savant Lumbar Interbody Fusion System — Curiteva, LLC
- Savant Lumbar Interbody Fusion System — Curiteva, LLC
- Savant Lumbar Interbody Fusion System — Curiteva, LLC
- Savant Lumbar Interbody Fusion System — Curiteva, LLC
- Savant Lumbar Interbody Fusion System — Curiteva, LLC
- Savant Lumbar Interbody Fusion System — Curiteva, LLC
- Savant Lumbar Interbody Fusion System — Curiteva, LLC
- Savant Lumbar Interbody Fusion System — Curiteva, LLC
- Savant Lumbar Interbody Fusion System — Curiteva, LLC
- Savant Lumbar Interbody Fusion System — Curiteva, 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
- Curiteva, LLC
Sources (1)
- FDA UDI 2e3cc7d5-ace0-4589-bcdb-096f8031fbe6 35 fields · synced May 31, 2026