Identity
- Trade Name
- NewPort FDA UDI
- Generic Name
- Orthopaedic implant-instrument extension adaptor, reusable FDA UDI
- Device Name
- Articulating Arm 1 FDA UDI
- Model / Reference
- 91-8329 FDA UDI
- Description
- Articulating Arm 1 FDA UDI
Identifiers
- Catalog Number
- 91-8329 FDA UDI
- Primary DI / UDI-DI
- 10889981084165 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic implant-instrument extension adaptor, 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
Yes
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
Yes
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: Orthopaedic implant-instrument extension adaptor, reusable
NewPort by SeaSpine Orthopedics Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic implant-instrument extension adaptor, reusable.
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- ACS® — implantcast GmbH · Class I
- Shukla Copter S9COPTER — Shukla Medical · Class I
- HEX DRIVE ATRAUMATIC RMR — Zimmer, Inc. · Class I
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
- SeaSpine Orthopedics Corporation
Sources (1)
- FDA UDI 2f20c953-5dc3-432b-9d29-c870e5e09a21 35 fields · synced Jun 8, 2026