Identity
- Trade Name
- SCS CLARIS SPINAL SYSTEM FDA UDI
- Generic Name
- Manual orthopaedic bender, reusable FDA UDI
- Device Name
- UNIV,ROD BENDER,FRENCH FDA UDI
- Model / Reference
- 2070-5023 FDA UDI
- Description
- UNIV,ROD BENDER,FRENCH FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840996174404 FDA UDI
- 510(k) Number
- K021379 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Manual orthopaedic bender, reusable 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Manual orthopaedic bender, reusable
Scs Claris Spinal System by Choicespine, LP — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Manual orthopaedic bender, reusable.
- MESA Small Stature Spinal System — K2M, INC. · Class I
- Invictus — ALPHATEC SPINE, INC. · Class I
- Kestrel® — Innovasis, Inc. · Class II
- Surgical Instrument — OSTEONIC CO., Ltd. · Class I
- Invictus — ALPHATEC SPINE, INC. · Class I
- Dark Star Deformity — Republic Spine, LLC · Class II
- g Source — GSOURCE, LLC. · Class I
- CLAW CHARLOTTE — WRIGHT MEDICAL TECHNOLOGY, INC. · Class I
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
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 |
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Manufacturer
- Manufacturer
- Choicespine, LP
Sources (1)
- FDA UDI 5c9af5e1-56d8-4b97-b52d-0cdb0b0eb084 35 fields · synced Jun 6, 2026