Identity
- Trade Name
- Titan Modular Shoulder System 2.5 FDA UDI
- Generic Name
- Surgical soft-tissue manipulation forceps, alligator, reusable FDA UDI
- Device Name
- TSS BODY SCREW FDA UDI
- Model / Reference
- BSW-0920-021-01 FDA UDI
- Description
- TSS BODY SCREW FDA UDI
Identifiers
- Catalog Number
- BSW-0920-021-01 FDA UDI
- Primary DI / UDI-DI
- 00885556859537 FDA UDI
- FDA Product Code
- KWS FDA UDIHSD FDA UDI
- GMDN Term
- Surgical soft-tissue manipulation forceps, alligator, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3660 FDA UDI888.3690 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical soft-tissue manipulation forceps, alligator, reusable
Titan Modular Shoulder System 2.5 by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical soft-tissue manipulation forceps, alligator, reusable.
- Integra® — Integra LifeSciences Production Corporation · Class I
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
- Symmetry Goodhill — SYMMETRY SURGICAL INC. · Class I
- JEDMED — JEDMED Instrument Company · Class I
- BOSS Instruments — Boss Instruments, Ltd. · Class I
- Micro laryngeal forceps — Spiggle & Theis Medizintechnik GmbH · Class I
- Symmetry Jako — SYMMETRY SURGICAL INC. · Class I
- Marina Medical — MARINA MEDICAL INSTRUMENTS, INC. · Class I
Cleared under the same submission
K100448 also covers:
- Titan Modular Shoulder System 2.5 — Smith & Nephew, Inc.
- Titan Modular Shoulder System 2.5 — Smith & Nephew, Inc.
- Titan Modular Shoulder System 2.5 — Smith & Nephew, Inc.
- Titan Modular Shoulder System 2.5 — Smith & Nephew, Inc.
- Titan Modular Shoulder System 2.5 — Smith & Nephew, Inc.
- Titan Modular Shoulder System 2.5 — Smith & Nephew, Inc.
- Titan Modular Shoulder System 2.5 — Smith & Nephew, Inc.
- Titan Modular Shoulder System 2.5 — Smith & Nephew, Inc.
- Titan Modular Shoulder System 2.5 — Smith & Nephew, Inc.
- Titan Modular Shoulder System 2.5 — Smith & Nephew, Inc.
- Titan Modular Shoulder System 2.5 — Smith & Nephew, Inc.
- Titan Modular Shoulder System 2.5 — Smith & Nephew, Inc.
K142413 also covers:
- Integra® — Ascension Orthopedics, Inc.
- Titan™ — Ascension Orthopedics, Inc.
- Titan™ — Ascension Orthopedics, Inc.
- Titan™ — Ascension Orthopedics, Inc.
- Titan™ Total Shoulder System — Ascension Orthopedics, Inc.
- Titan™ Total Shoulder System — Ascension Orthopedics, Inc.
- Titan™ Total Shoulder System — Ascension Orthopedics, Inc.
- Titan™ Total Shoulder System — Ascension Orthopedics, Inc.
- Titan™ Total Shoulder System — Ascension Orthopedics, Inc.
- Titan™ Total Shoulder System — Ascension Orthopedics, Inc.
- Titan™ Total Shoulder System — Ascension Orthopedics, Inc.
- Titan™ Total Shoulder System — Ascension Orthopedics, Inc.
K213827 also covers:
- Katalyst Biopolar Radial Head System — Smith & Nephew, Inc.
- Katalyst Bipolar Radial Head System — Smith & Nephew, Inc.
- Modular Radial Head (MRH) System — Smith & Nephew, Inc.
- Modular Radial Head (MRH) System — Smith & Nephew, Inc.
- Modular Radial Head (MRH) System — Smith & Nephew, Inc.
- Titan Humeral Resurfacing Arthroplasty — Smith & Nephew, Inc.
- Titan Humeral Resurfacing Arthroplasty — Smith & Nephew, Inc.
- Titan Modular Shoulder System — Smith & Nephew, Inc.
- Titan Modular Shoulder System — Smith & Nephew, Inc.
- Titan Modular Shoulder System 2.5 — Smith & Nephew, Inc.
- Titan Modular Shoulder System 2.5 — Smith & Nephew, Inc.
- Titan Modular Shoulder System 2.5 — Smith & Nephew, 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
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI 0bce96d7-a642-4a61-b096-7ab4fa9b10b9 36 fields · synced Jun 6, 2026