← Back to catalogue

Affix

FDA UDI

Class II (US FDA UDI)

by Nuvasive, Inc.

Identity

Trade Name
Affix FDA UDI
Generic Name
Lumbar decompression interspinous spacer FDA UDI
Device Name
Affix II S Bladed Plate, 45mm FDA UDI
Model / Reference
7571145 FDA UDI
Description
Affix II S Bladed Plate, 45mm FDA UDI

Identifiers

Primary DI / UDI-DI
00887517059185 FDA UDI
510(k) Number
K073278 FDA UDI
K131238 FDA UDI
K132411 FDA UDI
K133052 FDA UDI
K143388 FDA UDI
FDA Product Code
KWP FDA UDI
PEK 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

No

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

Category: Lumbar decompression interspinous spacer

Affix by Nuvasive, Inc. — 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

K073278 also covers:

K131238 also covers:

K132411 also covers:

K133052 also covers:

K143388 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Nuvasive, Inc.

Sources (1)

  • FDA UDI d4e2a1fe-e033-4c83-af76-9631a400a91e 35 fields · synced May 30, 2026