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Cross-Fuse™* Ii Peek Vbr/Ibf System

FDA UDI

Class II (US FDA UDI)

by Pioneer Surgical Technology, Inc.

Identity

Trade Name
CROSS-FUSE™* II PEEK VBR/IBF SYSTEM FDA UDI
Generic Name
Vertebral body prosthesis FDA UDI
Device Name
Crossfuse II Implant, 14x45x15 FDA UDI
Model / Reference
38-1445-15 FDA UDI
Description
Crossfuse II Implant, 14x45x15 FDA UDI

Identifiers

Catalog Number
38-1445-15 FDA UDI
Primary DI / UDI-DI
00846468007201 FDA UDI
FDA Product Code
ODP FDA UDI
MAX 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

Cross-Fuse™* Ii 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 1512619c-0054-45a0-b2f4-c6082a82ef03 36 fields · synced Jun 8, 2026