Identity
- Trade Name
- In2Bones FDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- T15 DRIVER, AO, Non-Sterile FDA UDI
- Model / Reference
- P07 N0041 FDA UDI
- Description
- T15 DRIVER, AO, Non-Sterile FDA UDI
Identifiers
- Catalog Number
- P07 N0041 FDA UDI
- Primary DI / UDI-DI
- 00810021862538 FDA UDI
- 510(k) Number
- K181113 FDA UDI
- FDA Product Code
- HWR FDA UDI
- GMDN Term
- Surgical screwdriver, reusable 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
Moist Heat or Steam Sterilization FDA UDI
MR Safe FDA UDI
Category: Surgical screwdriver, reusable
In2Bones by In2Bones, USA — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical screwdriver, reusable.
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- MEGA PLUS SPINE SYSTEM — BK MEDITECH CO., LTD. · Class I
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- PERLA ® TL — Spineart · Class II
- USS — Synthes · Class I
- Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · Class I
- CosmoLock Pedicle Screw System — Kalitec Direct LLC · Class I
Cleared under the same submission
K181113 also covers:
- CoLink® — Conmed Corporation
- CoLink® — Conmed Corporation
- CoLink® — Conmed Corporation
- CoLink® — Conmed Corporation
- CoLink® — Conmed Corporation
- CoLink® — Conmed Corporation
- CoLink® — Conmed Corporation
- AFX — In2Bones, USA
- CoLink Afx — In2Bones, USA
- CoLink Afx — In2Bones, USA
- CoLink Afx — In2Bones, USA
- CoLink™ Afx — In2Bones, USA
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 00fff99a-5bc2-4abb-adac-eb54b2f37a93 36 fields · synced May 31, 2026