Identity
- Trade Name
- Titanium-TSY™ Shoulder Plate FDA UDI
- Generic Name
- Orthopaedic bone screw, non-bioabsorbable, sterile FDA UDI
- Device Name
- 25mm Titanium Compression Screw FDA UDI
- Model / Reference
- TCS-025 FDA UDI
- Description
- 25mm Titanium Compression Screw FDA UDI
Identifiers
- Catalog Number
- TCS-025 FDA UDI
- Primary DI / UDI-DI
- 00813892020700 FDA UDI
- 510(k) Number
- K063033 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Orthopaedic bone screw, non-bioabsorbable, sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Dimensions & Sizes
- Size
- Length — 25 Millimeter FDA UDI
Category: Orthopaedic bone screw, non-bioabsorbable, sterile
The Titanium-TSY Shoulder Plate is a high-quality, medical device designed for internal orthopedic fracture fixation. Made from 25mm titanium compression screws, this device provides stable and secure fixation of bone fragments or soft tissue attachment.
Similar devices
Also classified as Orthopaedic bone screw, non-bioabsorbable, sterile.
- EPS Plating System Screw — GRAMERCY EXTREMITY ORTHOPEDICS, LLC. · Class II
- A.L.P.S.CORTICAL SCREW — Biomet Orthopedics, Inc. · Class II
- Peri-Loc — Smith & Nephew, Inc. · Class II
- Cortical Screw 2.5mm x 24mm Sterile — BIOPRO, INC. · Class II
- OsteoMed — Osteomed Corp. · Class II
- 3.5mm x 10mm Ti Cortical Screw — WISHBONE MEDICAL INC. · Class II
- primaLOK FF — Wenzel Spine · U
- MAX VPC™VARIABLE PITCH COMPRESSION SCREW — Biomet Orthopedics, Inc. · Class II
Cleared under the same submission
K063033 also covers:
- Titanium-TSY™ Shoulder Plate — ORTHOPEDIC SCIENCES, INC
- Titanium-TSY™ Shoulder Plate — ORTHOPEDIC SCIENCES, INC
- Titanium-TSY™ Shoulder Plate — ORTHOPEDIC SCIENCES, INC
- Titanium-TSY™ Shoulder Plate — ORTHOPEDIC SCIENCES, INC
- Titanium-TSY™ Shoulder Plate — ORTHOPEDIC SCIENCES, INC
- Titanium-TSY™ Shoulder Plate — ORTHOPEDIC SCIENCES, INC
- Titanium-TSY™ Shoulder Plate — ORTHOPEDIC SCIENCES, INC
- Titanium-TSY™ Shoulder Plate — ORTHOPEDIC SCIENCES, INC
- Titanium-TSY™ Shoulder Plate — ORTHOPEDIC SCIENCES, INC
- Titanium-TSY™ Shoulder Plate — ORTHOPEDIC SCIENCES, INC
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
- Orthopedic Sciences, Inc
Sources (1)
- FDA UDI 69c7323b-710b-4068-96fe-e49cdc45ee9a 38 fields · synced Jul 1, 2026