Identity
- Trade Name
- SCS CLARIS Spinal System FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system, non-sterile FDA UDI
- Device Name
- CLARIS,CONNECTOR,LATERAL,EXTREMITY,M6 FDA UDI
- Model / Reference
- 7T20-AL09 FDA UDI
- Description
- CLARIS,CONNECTOR,LATERAL,EXTREMITY,M6 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840996122887 FDA UDI
- 510(k) Number
- K021379 FDA UDI
- FDA Product Code
- MNH FDA UDIKWQ FDA UDIKWP FDA UDIMNI FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 FDA UDI888.3060 FDA UDI888.3050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Bone-screw internal spinal fixation system, non-sterile
The SCS CLARIS Spinal System is a high-performance, non-sterile disposable bone-screw internal spinal fixation system designed for the treatment of various spinal instabilities or deformities. This system consists of a combination of anchors, interconnection mechanisms, longitudinal members, and/or transverse connectors, typically used in conjunction with implantation.
Similar devices
Also classified as Bone-screw internal spinal fixation system, non-sterile.
- TIGER Spine System — CORELINK LLC · Class II
- The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
- SILVERTON SPINAL FIXATION SYSTEM — BIOMET SPINE LLC · Class II
- POLARIS™ 5.5 SPINAL SYSTEM — BIOMET SPINE LLC · Class II
- Vitality® — BIOMET SPINE LLC · Class II
- The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
- PASS LP — Medicrea International SA · Class II
- The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
Cleared under the same submission
K021379 also covers:
- SCS CLARIS SPINAL SYSTEM — Choicespine, LP
- SCS CLARIS SPINAL SYSTEM — Choicespine, LP
- SCS CLARIS Spinal System — Choicespine, LP
- SCS CLARIS Spinal System — Choicespine, LP
- SCS CLARIS Spinal System — Choicespine, LP
- SCS CLARIS Spinal System — Choicespine, LP
- SCS CLARIS Spinal System — Choicespine, LP
- SCS CLARIS Spinal System — Choicespine, LP
Authorization Coverage (1 country)
Regulatory Authorizations
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
- Choicespine, LP
Sources (1)
- FDA UDI 52db9bf7-4cca-4bd5-9225-d3a2580867a6 35 fields · synced Jul 11, 2026