← Back to catalogue
Altus Spine Cervical Interbody Fusion System
FDA UDIClass II (US FDA UDI)
by Altus Spine
Identity
- Trade Name
- Altus Spine Cervical Interbody Fusion System FDA UDI
- Generic Name
- Bone file/rasp, manual, reusable FDA UDI
- Device Name
- Rasp, W/Tab FDA UDI
- Model / Reference
- 210-3104 FDA UDI
- Description
- Rasp, W/Tab FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00843210131184 FDA UDI
- 510(k) Number
- K172253 FDA UDI
- FDA Product Code
- ODP FDA UDI
- GMDN Term
- Bone file/rasp, manual, reusable 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
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
Dimensions & Sizes
- Size
- Height — 4 Millimeter FDA UDI
Category: Bone file/rasp, manual, reusable
Altus Spine Cervical Interbody Fusion System by Altus Spine — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone file/rasp, manual, reusable.
- Integra® Jarit® — Integra LifeSciences Production Corporation · Class I
- NORDENT MANUFACTURING INC — NORDENT MANUFACTURING INC · Class I
- Life Instruments — Life Instrument Corporation · Class I
- TALOS®-C — MEDITECH SPINE, LLC · Class II
- DeGen Standard Instrumentation — Degen Medical · Class I
- TiWave C Cervical Cage System — Kalitec Direct LLC · Class I
- BOSS Instruments — Boss Instruments, Ltd. · Class I
- 4WEB Medical — 4Web Medical, Inc. · Class I
Cleared under the same submission
K172253 also covers:
- Altus Spine Cervical Interbody Fusion System — Altus Spine
- Altus Spine Cervical Interbody Fusion System — Altus Spine
- Altus Spine Cervical Interbody Fusion System — Altus Spine
- Altus Spine Cervical Interbody Fusion System — Altus Spine
- Altus Spine Cervical Interbody Fusion System — Altus Spine
- Altus Spine Cervical Interbody Fusion System — Altus Spine
- Altus Spine Cervical Interbody Fusion System — Altus Spine
- Altus Spine Cervical Interbody Fusion System — Altus Spine
- Altus Spine Cervical Interbody Fusion System — Altus Spine
- Suzuka Interbody Fusion System — Altus Spine
- Suzuka Interbody Fusion System — Altus Spine
- Suzuka Interbody Fusion System — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Altus Spine
Sources (1)
- FDA UDI b19314c3-c0a4-4666-a1b0-3bc7e18bd56a 36 fields · synced May 30, 2026