Identity
- Trade Name
- Redondo-L FDA UDI
- Generic Name
- Vertebral body prosthesis, non-sterile FDA UDI
- Device Name
- 55mm x 18mm x 14mm, 8 Deg FDA UDI
- Model / Reference
- 36-5514 FDA UDI
- Description
- 55mm x 18mm x 14mm, 8 Deg FDA UDI
Identifiers
- Catalog Number
- 36-5514 FDA UDI
- Primary DI / UDI-DI
- 10889981035273 FDA UDI
- 510(k) Number
- K103297 FDA UDI
- FDA Product Code
- MAX FDA UDI
- GMDN Term
- Vertebral body prosthesis, non-sterile 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
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
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: Vertebral body prosthesis, non-sterile
Redondo-L by SeaSpine Orthopedics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K103297 also covers:
- Redondo-L — SeaSpine Orthopedics Corporation
- Redondo-L — SeaSpine Orthopedics Corporation
- Redondo-L — SeaSpine Orthopedics Corporation
- Redondo-L™ — SeaSpine Orthopedics Corporation
- Redondo-L™ — SeaSpine Orthopedics Corporation
- Redondo-L™ — SeaSpine Orthopedics Corporation
- Redondo-L™ — SeaSpine Orthopedics Corporation
- Redondo-L™ — SeaSpine Orthopedics Corporation
- Redondo-L™ — SeaSpine Orthopedics Corporation
- Redondo-L™ — SeaSpine Orthopedics Corporation
- Redondo-L™ — SeaSpine Orthopedics Corporation
- Redondo-L™ — 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 4b2f88bf-e99a-495b-8f26-782863e19676 37 fields · synced Jun 8, 2026