Identity
- Trade Name
- In2Bones FDA UDI
- Generic Name
- Orthopaedic surgical distractor, external FDA UDI
- Device Name
- COBB ELEVATOR, 3/8" FDA UDI
- Model / Reference
- P08 N0021 FDA UDI
- Description
- COBB ELEVATOR, 3/8" FDA UDI
Identifiers
- Catalog Number
- P08 N0021 FDA UDI
- Primary DI / UDI-DI
- 00810021862163 FDA UDI
- 510(k) Number
- K200762 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic surgical distractor, external 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
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
Yes
FDA UDI
MR Safe FDA UDI
Category: Orthopaedic surgical distractor, external
In2Bones by In2Bones, USA — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic surgical distractor, external.
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- MSI — Modern Surgical Instruments LLC · Class I
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- Arthrex® — Arthrex, Inc. · Class I
- Arthrex® — Arthrex, Inc. · Class I
- Innomed, Inc. — Innomed, Inc. · Class I
Cleared under the same submission
K200762 also covers:
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
- In2Bones, USA
Sources (1)
- FDA UDI d7e0b048-7945-4090-a394-becde39bde93 36 fields · synced Jun 1, 2026