Identity
- Trade Name
- CoRoent FDA UDI
- Generic Name
- Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
- Device Name
- CoRoent XL-W Inserter, 12-24 FDA UDI
- Model / Reference
- 1633150 FDA UDI
- Description
- CoRoent XL-W Inserter, 12-24 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00887517621689 FDA UDI
- 510(k) Number
- K170962 FDA UDI
- FDA Product Code
- MAX FDA UDIPHM FDA UDI
- GMDN Term
- Orthopaedic inorganic implant inserter/extractor, 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
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
No
Category: Orthopaedic inorganic implant inserter/extractor, reusable
CoRoent XL-W Inserter is a reusable hand-held manual surgical instrument designed for the precise insertion and extraction of orthopaedic implants, including non-tissue-based inorganic orthopaedic implant devices. It features a modular design with a region that attaches to part of the implant, providing an optimal way to deploy guides for accurate implantation.
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
- TIMBERLINE LATERAL FUSION SYSTEM — BIOMET SPINE LLC · Class II
- General Instruments — ALPHATEC SPINE, INC. · Class I
Cleared under the same submission
K170962 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
- Nuvasive, Inc.
Sources (1)
- FDA UDI 01fa4f76-ca86-49f9-9a35-fd675a356bfe 35 fields · synced Oct 6, 2026