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Distract-Then-Rotate™* Peek Vbr/Ibf System

FDA UDI

Class II (US FDA UDI)

by Pioneer Surgical Technology, Inc.

Identity

Trade Name
DISTRACT-THEN-ROTATE™* PEEK VBR/IBF SYSTEM FDA UDI
Generic Name
Vertebral body prosthesis FDA UDI
Device Name
11x20 Implant, Rotate Option, VBR FDA UDI
Model / Reference
33-11-20 FDA UDI
Description
11x20 Implant, Rotate Option, VBR FDA UDI

Identifiers

Catalog Number
33-11-20 FDA UDI
Primary DI / UDI-DI
00846468034917 FDA UDI
FDA Product Code
MAX FDA UDI
ODP FDA UDI
MQP FDA UDI
GMDN Term
Vertebral body prosthesis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3080 FDA UDI
888.3060 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Distract-Then-Rotate™* Peek Vbr/Ibf System by Pioneer Surgical Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Pioneer Surgical Technology, Inc.

Sources (1)

  • FDA UDI ce9e50fd-0eef-4310-a849-1fda3d97c8c4 36 fields · synced Jun 1, 2026