Identity
- Trade Name
- Shoreline ACS FDA UDI
- Generic Name
- Metal-polymer composite spinal interbody fusion cage FDA UDI
- Device Name
- 14x13x9mm, 7 Degree, Interbody FDA UDI
- Model / Reference
- 85-0809 FDA UDI
- Description
- 14x13x9mm, 7 Degree, Interbody FDA UDI
Identifiers
- Catalog Number
- 85-0809 FDA UDI
- Primary DI / UDI-DI
- 10889981124434 FDA UDI
- 510(k) Number
- K161081 FDA UDI
- FDA Product Code
- OVE FDA UDI
- GMDN Term
- Metal-polymer composite spinal interbody fusion cage FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Metal-polymer composite spinal interbody fusion cage
Shoreline ACS by SeaSpine Orthopedics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Metal-polymer composite spinal interbody fusion cage.
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- LUCENT XP ARC — SPINAL ELEMENTS, INC. · Class II
- MIDLINE II-Ti — Centinel Spine, LLC · Class II
- Latitude-C Cervical Interbody Spacer System — Degen Medical · Class II
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Cleared under the same submission
K161081 also covers:
- Shoreline — SeaSpine Orthopedics Corporation
- Shoreline ACS — SeaSpine Orthopedics Corporation
- Shoreline ACS — SeaSpine Orthopedics Corporation
- Shoreline ACS — SeaSpine Orthopedics Corporation
- Shoreline ACS — SeaSpine Orthopedics Corporation
- Shoreline ACS — SeaSpine Orthopedics Corporation
- Shoreline ACS — SeaSpine Orthopedics Corporation
- Shoreline ACS — SeaSpine Orthopedics Corporation
- Shoreline ACS — SeaSpine Orthopedics Corporation
- Shoreline ACS — SeaSpine Orthopedics Corporation
- Shoreline ACS — SeaSpine Orthopedics Corporation
- Shoreline ACS — SeaSpine Orthopedics Corporation
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 |
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Manufacturer
- Manufacturer
- SeaSpine Orthopedics Corporation
Sources (1)
- FDA UDI e8696cad-a933-4d79-9b55-164290f3cae3 37 fields · synced Jun 8, 2026