Identity
- Trade Name
- Erisma®-LP FDA UDI
- Generic Name
- Spinal bone set screw FDA UDI
- Device Name
- SET SCREW FDA UDI
- Model / Reference
- 13620009 FDA UDI
- Description
- SET SCREW FDA UDI
Identifiers
- Catalog Number
- 13620009 FDA UDI
- Primary DI / UDI-DI
- 03700780616251 FDA UDI
- 510(k) Number
- K162367 FDA UDI
- FDA Product Code
- NKB FDA UDIMNH FDA UDIMNI FDA UDI
- GMDN Term
- Spinal bone set screw FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 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
Category: Spinal bone set screw
Erisma®-LP by Clariance, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Spinal bone set screw.
- COSY — SIGNUS Medizintechnik GmbH · Class II
- Vertefix II — ELITE SURGICAL SUPPLIES (PTY) LTD · Class II
- 4CIS APOLLON SPINE SYSTEM — ALPHANOX CO., LTD. · Class II
- Momentum — ULRICH MEDICAL USA, INC. · Class II
- SET SCREW — OsteoCentric Technologies,Inc · Class II
- Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · Class II
- Annex® Adjacent Level System — Spine Wave, Inc. · Class II
- Vertefix II — ELITE SURGICAL SUPPLIES (PTY) LTD · 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 (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
- Clariance, Inc.
Sources (1)
- FDA UDI ab39fd13-a31a-446d-9ff1-4c01cdb98bf2 36 fields · synced May 30, 2026