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Vertebral Spacer-Pr

FDA UDI

Class II (US FDA UDI)

by Synthes (u.s.a.) Lp

Identity

Trade Name
VERTEBRAL SPACER-PR FDA UDI
Generic Name
Polymeric spinal interbody fusion cage FDA UDI
Device Name
VERTEBRAL SPACER-PR 10MMX24MM 13MM HEIGHT FDA UDI
Model / Reference
08.803.025 FDA UDI
Description
VERTEBRAL SPACER-PR 10MMX24MM 13MM HEIGHT FDA UDI

Identifiers

Catalog Number
08803025 FDA UDI
Primary DI / UDI-DI
10705034754178 FDA UDI
510(k) Number
K011037 FDA UDI
FDA Product Code
MQP FDA UDI
GMDN Term
Polymeric spinal interbody fusion cage FDA UDI

Classification

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

Clinical & Handling

Sterile

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Vertebral Spacer-Pr by Synthes (u.s.a.) Lp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K011037 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Synthes (u.s.a.) Lp

Sources (1)

  • FDA UDI 767cabd9-485e-46fa-9e64-951ffd7e9804 37 fields · synced Jun 1, 2026