Identity
- Trade Name
- ESTREMO FDA UDI
- Generic Name
- Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
- Model / Reference
- Impaction bolt, cannulated FDA UDI
Identifiers
- Catalog Number
- EBA-5317 FDA UDI
- Primary DI / UDI-DI
- 08051739535815 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3020 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Orthopaedic inorganic implant inserter/extractor, reusable
The ESTREMO device is a hand-held, orthopaedic inorganic implant inserter/extractor designed for the surgical insertion and/or extraction of non-tissue-based implants. It features a one-piece or modular configuration with a region that attaches/fits/locks to part of the implant, typically using a mechanism such as twisting (screwing) or plunger deployment. The device is reusable and can be used in both clinical and research settings.
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
- PAR 5 RING-LOC — Biomet Orthopedics, Inc. · Class I
- 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
K181540 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
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
- Citieffe
Sources (1)
- FDA UDI 9e2fa711-188c-4dd8-83c1-d02249f90846 36 fields · synced Jul 24, 2026