Identity
- Trade Name
- Inserter/Extractor FDA UDI
- Generic Name
- Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
- Device Name
- Reusable surgical instrument used to engage the proximal end of the flexible CurvaFix® IM Implant in preparation for insertion into the intramedullary canal for implantation. If needed, device can also be used to engage the implant during a removal procedure. FDA UDI
- Model / Reference
- CIA-001 FDA UDI
- Description
- Reusable surgical instrument used to engage the proximal end of the flexible CurvaFix® IM Implant in preparation for insertion into the intramedullary canal for implantation. If needed, device can also be used to engage the implant during a removal procedure. FDA UDI
Identifiers
- Catalog Number
- CIA-001 FDA UDI
- Primary DI / UDI-DI
- 10855068008348 FDA UDI
- 510(k) Number
- K180050 FDA UDI
- FDA Product Code
- HSB FDA UDIHWC FDA UDI
- GMDN Term
- Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3020 FDA UDI888.3040 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 inorganic implant inserter/extractor, reusable
Inserter/Extractor by Curvafix Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic inorganic implant inserter/extractor, reusable.
- Omnia Medical Golden Spike — Omnia Medical · Class I
- Calibrate — ALPHATEC SPINE, INC. · Class II
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- Made-To-Order — TORNIER, INC. · Class I
- Vu ePOD™ — SeaSpine Orthopedics Corporation · Class II
- Mariner MCT — SeaSpine Orthopedics Corporation · Class II
- PEEK Corpectomy — Nuvasive, Inc. · Class II
- TIMBERLINE LATERAL FUSION SYSTEM — BIOMET SPINE LLC · Class II
Cleared under the same submission
K180050 also covers:
- CurvaFix® IM Implant — Curvafix Inc
- CurvaFix® IM Implant — Curvafix Inc
- CurvaFix® IM Implant — Curvafix Inc
- CurvaFix® IM Implant — Curvafix Inc
- CurvaFix® IM Implant — Curvafix Inc
- CurvaFix® IM Implant — Curvafix Inc
- CurvaFix® IM Implant — Curvafix Inc
- CurvaFix® IM Implant — Curvafix Inc
- CurvaFix® IM Implant — Curvafix Inc
- CurvaFix® IM Implant — Curvafix Inc
- CurvaFix® IM Implant — Curvafix Inc
- Inserter/Extractor — Curvafix 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
- Curvafix Inc
Sources (1)
- FDA UDI 3210424a-7b95-4f03-8c66-57cb1be966df 36 fields · synced Jun 6, 2026