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True Tulip Spinal Fixation System

FDA UDI

Class II (US FDA UDI)

by Innovative Surgical Designs, Inc.

Identity

Trade Name
True Tulip Spinal Fixation System FDA UDI
Generic Name
Bone-screw internal spinal fixation system, sterile FDA UDI
Device Name
6.5 mm x 50 mm True MIS Pedicle Screw FDA UDI
Model / Reference
205-9-308-650 FDA UDI
Description
6.5 mm x 50 mm True MIS Pedicle Screw FDA UDI

Identifiers

Primary DI / UDI-DI
B50620593086501 FDA UDI
FDA Product Code
NKB FDA UDI
KWP FDA UDI
GMDN Term
Bone-screw internal spinal fixation system, sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3070 FDA UDI
888.3050 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

Yes

FDA UDI
Sterilization Method
Radiation Sterilization FDA UDI

Category: Bone-screw internal spinal fixation system, sterile

True Tulip Spinal Fixation System by Innovative Surgical Designs, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone-screw internal spinal fixation system, sterile.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Innovative Surgical Designs, Inc.

Sources (1)

  • FDA UDI 319296f0-223f-4862-a819-0a29142cf7f5 33 fields · synced Jun 1, 2026