Identity
- Trade Name
- Pisces-SA FDA UDI
- Generic Name
- Orthopaedic surgical distractor, internal FDA UDI
- Device Name
- Cobb Elevator, 15mm FDA UDI
- Model / Reference
- 1760-7000 FDA UDI
- Description
- Cobb Elevator, 15mm FDA UDI
Identifiers
- Catalog Number
- 1760-7000 FDA UDI
- Primary DI / UDI-DI
- B06217607000 FDA UDI
- 510(k) Number
- K213935 FDA UDI
- FDA Product Code
- GEG FDA UDI
- GMDN Term
- Orthopaedic surgical distractor, internal FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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: Orthopaedic surgical distractor, internal
Pisces-SA by Osseus Fusion Systems Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Osseus Fusion Systems Llc
Sources (1)
- FDA UDI 7b90db8e-f83f-4055-a0ee-d9a63de0bc4b 35 fields · synced Jun 1, 2026