Identity
- Trade Name
- Pisces-SA FDA UDI
- Generic Name
- Surgical instrument torque limiter FDA UDI
- Device Name
- Counter-Torque FDA UDI
- Model / Reference
- 1750-0026 FDA UDI
- Description
- Counter-Torque FDA UDI
Identifiers
- Catalog Number
- 1750-0026 FDA UDI
- Primary DI / UDI-DI
- B06217500026 FDA UDI
- 510(k) Number
- K213935 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Surgical instrument torque limiter 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
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: Surgical instrument torque limiter
Pisces-SA by Osseus Fusion Systems Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical instrument torque limiter.
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- Titan Modular Shoulder System 2.5 — Smith & Nephew, Inc. · Class I
- Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
- CarboClear X Pedicle Screw System — CARBOFIX ORTHOPEDICS LTD · Class II
- MobileLink Acetabular Cup System - Instruments — WALDEMAR LINK GmbH & Co. KG · Class I
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 839e9f95-d9ca-4d1f-ad7c-738a4de0aa31 35 fields · synced Jun 8, 2026