Identity
- Trade Name
- Pisces-SA FDA UDI
- Generic Name
- Metallic spinal interbody fusion cage FDA UDI
- Device Name
- Bone Screw, Variable, Self-Tapping, 17.5mm, PISCES-SA FDA UDI
- Model / Reference
- 1720-5018 FDA UDI
- Description
- Bone Screw, Variable, Self-Tapping, 17.5mm, PISCES-SA FDA UDI
Identifiers
- Catalog Number
- 1720-5018 FDA UDI
- Primary DI / UDI-DI
- B06217205018 FDA UDI
- 510(k) Number
- K213935 FDA UDI
- FDA Product Code
- OVD FDA UDI
- GMDN Term
- Metallic 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
MR Conditional FDA UDI
Category: Metallic spinal interbody fusion cage
Pisces-SA by Osseus Fusion Systems Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Metallic spinal interbody fusion cage.
- KODIAK CERVICAL IMPLANT, 14x16mm, 10mmx6° — MET 1 TECHNOLOGIES, LLC · Class II
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- CoRoent — Nuvasive, Inc. · Class II
- Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II
- MectaLIF 3D — Medacta International · Class II
- PILLAR TL — Orthofix US LLC · Class II
- Solar™ Interbody Fusion System — Degen Medical · Class II
- Peridot-TD Anterior Cervical Intervertebral body fusion system — GBS Commonwealth Co., Ltd. · Class II
Cleared under the same submission
K213935 also covers:
- Pisces-SA — OSSEUS FUSION SYSTEMS LLC
- Pisces-SA — OSSEUS FUSION SYSTEMS LLC
- Pisces-SA — OSSEUS FUSION SYSTEMS LLC
- Pisces-SA — OSSEUS FUSION SYSTEMS LLC
- Pisces-SA — OSSEUS FUSION SYSTEMS LLC
- Pisces-SA — OSSEUS FUSION SYSTEMS LLC
- Pisces-SA — OSSEUS FUSION SYSTEMS LLC
- Pisces-SA — OSSEUS FUSION SYSTEMS LLC
- Pisces-SA — OSSEUS FUSION SYSTEMS LLC
- Pisces-SA — OSSEUS FUSION SYSTEMS LLC
- Pisces-SA — OSSEUS FUSION SYSTEMS LLC
- Pisces-SA — OSSEUS FUSION SYSTEMS LLC
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
- Osseus Fusion Systems Llc
Sources (1)
- FDA UDI da2b3d91-ac49-4679-8357-8e47fbec42f2 35 fields · synced May 30, 2026