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Spinous Process Plate, 12mm

FDA UDI

Class II (US FDA UDI)

by Surgentec Llc

Identity

Trade Name
Spinous Process Plate, 12mm FDA UDI
Generic Name
Lumbar decompression interspinous spacer FDA UDI
Model / Reference
SR08-4612 FDA UDI

Identifiers

Primary DI / UDI-DI
00810131880811 FDA UDI
510(k) Number
K110367 FDA UDI
FDA Product Code
KWP FDA UDI
GMDN Term
Lumbar decompression interspinous spacer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3050 FDA UDI
Commercial Distribution
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

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

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Lumbar decompression interspinous spacer

Spinous Process Plate, 12mm by Surgentec Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Lumbar decompression interspinous spacer.

Cleared under the same submission

K110367 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Surgentec Llc

Sources (1)

  • FDA UDI 46dfe56c-067d-4e82-98cc-4a467d3d02b5 33 fields · synced May 30, 2026