← Back to catalogue

Titanium-TSY™ Shoulder Plate

FDA UDI

Class II (US FDA UDI)

by Orthopedic Sciences, Inc

Identity

Trade Name
Titanium-TSY™ Shoulder Plate FDA UDI
Generic Name
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile FDA UDI
Device Name
130° Titanium-TSY™ Shoulder Plate FDA UDI
Model / Reference
TSP-130 FDA UDI
Description
130° Titanium-TSY™ Shoulder Plate FDA UDI

Identifiers

Catalog Number
TSP-130 FDA UDI
Primary DI / UDI-DI
00813892020748 FDA UDI
510(k) Number
K063033 FDA UDI
FDA Product Code
HRS FDA UDI
GMDN Term
Internal orthopaedic fixation system, plate/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
Angle — 130 degree FDA UDI

Category: Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile

Titanium-TSY™ Shoulder Plate by Orthopedic Sciences, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile.

Cleared under the same submission

K063033 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Orthopedic Sciences, Inc

Sources (1)

  • FDA UDI 5a2eea7c-58ae-414e-b6f2-ee0f3e2fabd7 38 fields · synced May 30, 2026