Identity
- Trade Name
- Suzuka Interbody Fusion System FDA UDI
- Generic Name
- Polymeric spinal interbody fusion cage FDA UDI
- Device Name
- Interbody Fusion Device, PEEK ALR FDA UDI
- Model / Reference
- ALR17-810 FDA UDI
- Description
- Interbody Fusion Device, PEEK ALR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00843210121123 FDA UDI
- 510(k) Number
- K172253 FDA UDI
- FDA Product Code
- ODP FDA UDI
- GMDN Term
- Polymeric spinal interbody fusion cage 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
Dimensions & Sizes
- Size
- Height — 10 Millimeter FDA UDIAngle — 8 degree FDA UDIWidth — 13.5 Millimeter FDA UDILength — 17 Millimeter FDA UDI
Category: Polymeric spinal interbody fusion cage
A comprehensive medical device directory listing the Suzuka Interbody Fusion System, including its version number, labeling status, and manufacturing information.
Similar devices
Also classified as Polymeric spinal interbody fusion cage.
- L-Box® — Innovasis, Inc. · Class II
- CoRoent — Nuvasive, Inc. · Class II
- Novel Spinal Spacer System — ALPHATEC SPINE, INC. · Class II
- S-LIFT® — SPINEFRONTIER, INC. · Class II
- Peridot Intervertebral body fusion system — GBS Commonwealth Co., Ltd. · Class II
- TAURUS PEEK Cage System — Medyssey Co., Ltd. · Class II
- Cross-Fuse® II PEEK IBF System — Rti Surgical, Inc. · Class II
- Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II
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
- Altus Spine Cervical 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 1d8c3439-5557-49e0-bed4-fe0bc367a10c 36 fields · synced Jul 15, 2026