Identity
- Trade Name
- VIS POLYAXIALE CANULÉE ( Ø 8,5 MM L 60 MM ) EUDAMEDErisma®-LP FDA UDI
- Generic Name
- Spinal bone screw, non-bioabsorbable FDA UDI
- Device Name
- CANNULATED POLYAXIAL SCREW FDA UDI
- Model / Reference
- 13028560 EUDAMEDFDA UDIPedicle screw EUDAMED
- Description
- CANNULATED POLYAXIAL SCREW FDA UDI
Identifiers
- Catalog Number
- 13028560 FDA UDI
- Primary DI / UDI-DI
- 03700780614769 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03700780614769 EUDAMED
- 510(k) Number
- K153326 FDA UDI
- FDA Product Code
- NKB FDA UDIMNI FDA UDIMNH FDA UDI
- EMDN Code
- P09070302 THORACOLUMBOSACRAL FIXATION SYSTEMS EUDAMED
- GMDN Term
- Spinal bone screw, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3070 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
- Length — 60 Millimeter FDA UDIOuter Diameter — 8.5 Millimeter FDA UDI
Category: Spinal bone screw, non-bioabsorbable
Erisma®-LP by Clariance, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Spinal bone screw, non-bioabsorbable.
- 4CIS® Chiron Spinal Fixation System — ALPHANOX CO., LTD. · Class II
- LnK/PathLoc-L MIS Spinal System — L&K BIOMED CO. , LTD. · Class II
- ASPIRON™ ACPSYSTEM — CG MedTech Co., Ltd. · Class II
- Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
- OpenLoc-L Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
- Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
- AccelFix Spinal Fixation System (Sterile) — L&K Biomed · Class IIb
- Proficient™ Posterior Cervical Spine System — Spine Wave, Inc. · Class II
Cleared under the same submission
K153326 also covers:
- Erisma®-LP — Clariance, Inc.
- Erisma®-LP — Clariance, Inc.
- Erisma®-LP — Clariance, Inc.
- Erisma®-LP — Clariance, Inc.
- Erisma®-LP — Clariance, Inc.
- Erisma®-LP — Clariance, Inc.
- Erisma®-LP — Clariance, Inc.
- Erisma®-LP — Clariance, Inc.
- Erisma®-LP — Clariance, Inc.
- Erisma®-LP — Clariance, Inc.
- Erisma®-LP — Clariance, Inc.
- Erisma®-LP — Clariance, Inc.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Clariance, Inc.
Sources (2)
- FDA UDI 63914e63-791b-46d9-a1f5-763643c1b0a9 37 fields · synced Jul 8, 2026
- EUDAMED 497ea8b7-370d-4a4b-910f-8f1cc1467a5b 61 fields · synced Jul 8, 2026