Identity
- Trade Name
- Indy Standalone FDA UDI
- Generic Name
- Bone tap, reprocessed FDA UDI
- Device Name
- U-Joint Ø4.2mm Tap, 25mm FDA UDI
- Model / Reference
- 1030-2425A FDA UDI
- Description
- U-Joint Ø4.2mm Tap, 25mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00843210177144 FDA UDI
- 510(k) Number
- K211837 FDA UDI
- FDA Product Code
- HWJ FDA UDI
- GMDN Term
- Bone tap, reprocessed 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
Category: Bone tap, reprocessed
Indy Standalone by Altus Spine — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone tap, reprocessed.
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- Boundary — NVISION BIOMEDICAL TECHNOLOGIES, INC · Class II
- Altus Spine Pedicle Screw System — Altus Spine · Class II
- Altus Spine Pedicle Screw System — Altus Spine · Class II
Cleared under the same submission
K211837 also covers:
- Brickyard Stand-Alone ALIF — Altus Spine
- Brickyard Stand-Alone ALIF — Altus Spine
- Brickyard Stand-Alone ALIF — Altus Spine
- Brickyard Stand-Alone ALIF — Altus Spine
- Brickyard Stand-Alone ALIF — Altus Spine
- Brickyard Stand-Alone ALIF — Altus Spine
- Brickyard Stand-Alone ALIF — Altus Spine
- Brickyard Stand-Alone ALIF — Altus Spine
- Brickyard Stand-Alone ALIF — Altus Spine
- Brickyard Stand-Alone ALIF — Altus Spine
- Brickyard Stand-Alone ALIF — Altus Spine
- Brickyard Stand-Alone ALIF — Altus Spine
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Altus Spine
Sources (1)
- FDA UDI d3edbf53-bda1-40bd-8530-773b679292cc 35 fields · synced May 30, 2026