Identity
- Trade Name
- InCore Subtalar FDA UDI
- Generic Name
- Orthopaedic inorganic implant inserter/extractor, single-use FDA UDI
- Device Name
- InCore Subtalar T25 Driver Disposable FDA UDI
- Model / Reference
- ICSUBT25D FDA UDI
- Description
- InCore Subtalar T25 Driver Disposable FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817701028796 FDA UDI
- 510(k) Number
- K213301 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic inorganic implant inserter/extractor, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthopaedic inorganic implant inserter/extractor, single-use
InCore Subtalar by Medartis Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K213301 also covers:
- InCore Subtalar — Medartis Inc.
- InCore Subtalar — Medartis Inc.
- InCore Subtalar — Medartis Inc.
- InCore Subtalar — Medartis Inc.
- InCore Subtalar — Medartis Inc.
- InCore Subtalar — Medartis Inc.
- InCore Subtalar — Medartis Inc.
- InCore Subtalar — Medartis Inc.
- InCore Subtalar — Medartis Inc.
- InCore Subtalar — Medartis Inc.
- InCore Subtalar — Medartis Inc.
- InCore Subtalar — Medartis 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 I | Pending data |
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Manufacturer
- Manufacturer
- Medartis Inc.
Sources (1)
- FDA UDI 384c86e8-61bf-450b-91e5-01a183cd4d04 34 fields · synced Jun 8, 2026