Identity
- Trade Name
- Indy Standalone FDA UDI
- Generic Name
- Lumbar total intervertebral disc prosthesis FDA UDI
- Device Name
- Titanium Blocking Plate, 13H mm FDA UDI
- Model / Reference
- SL0013 FDA UDI
- Description
- Titanium Blocking Plate, 13H mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00843210162225 FDA UDI
- 510(k) Number
- K211837 FDA UDI
- FDA Product Code
- OVD FDA UDIMAX FDA UDI
- GMDN Term
- Lumbar total intervertebral disc prosthesis 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
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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: Lumbar total intervertebral disc prosthesis
Indy Standalone by Altus Spine — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Lumbar total intervertebral disc prosthesis.
- Prodisc L — Centinel Spine, LLC · Class III
- activL® — AESCULAP, INC. · Class III
- 3DP Lumbar Interbody — Genesys Orthopedics Systems LLC · Class II
- ProDisc — SYNTHES (U.S.A.) LP · Class III
- ProDisc — SYNTHES (U.S.A.) LP · Class III
- Prodisc L — Centinel Spine, LLC · Class III
- activL® — AESCULAP, INC. · Class III
- activL® — AESCULAP, INC. · Class III
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 II | Pending data |
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Manufacturer
- Manufacturer
- Altus Spine
Sources (1)
- FDA UDI cf388cdf-aeed-40d6-b205-4f16834a0a9f 35 fields · synced May 31, 2026