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Erisma®-LP
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 13014545Model Pedicle screw system
Identity
- Trade Name
- VIS POLYAXIALE CANULEE MIS ( Ø 4,5 MM L 45 MM ) EUDAMEDErisma®-LP FDA UDI
- Generic Name
- Spinal bone screw, non-bioabsorbable FDA UDI
- Device Name
- Erisma LP MIS EUDAMEDMIS CANNULATED POLYAXIAL SCREW FDA UDI
- Model / Reference
- 13014545 EUDAMEDFDA UDIPedicle screw system EUDAMED
- Description
- MIS CANNULATED POLYAXIAL SCREW FDA UDI
Identifiers
- Catalog Number
- 13014545 FDA UDI
- Primary DI / UDI-DI
- 03700780614905 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03700780614905 EUDAMED
- 510(k) Number
- K162367 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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 — 45 Millimeter FDA UDIOuter Diameter — 4.5 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
K162367 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Clariance, Inc.
Sources (2)
- FDA UDI 334a70ed-a03c-4428-ac3b-e5f6db3ababf 37 fields · synced Jul 10, 2026
- EUDAMED c4fc64f4-4145-470d-96b4-0e6ec2f3cf9d 61 fields · synced Jul 10, 2026