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Affix 7571045

by NuVasive, LLC

Affix 7571045 is a Class II device made by NuVasive, LLC, cleared under FDA 510(k) K143388 on 5 Mar 2015 (4 earlier submissions) and listed in FDA GUDID since 4 Dec 2019 (UDI-DI 00887517058676), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00887517058676 UDI-DI Date4 Dec 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK143388 Date5 Mar 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K143388 decided 5 Mar 2015 Active· +4 more in the status table
  • FDA GUDID UDI-DI 00887517058676 listed 4 Dec 2019 Listed

Timeline

6 dated events

  1. Cleared FDA 510(k) K073278
  2. Cleared FDA 510(k) K131238
  3. Cleared FDA 510(k) K132411
  4. Cleared FDA 510(k) K133052
  5. Cleared FDA 510(k) K143388
  6. Listed FDA GUDID 00887517058676

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Affix
Generic name
Lumbar decompression interspinous spacer
Model / reference
7571045
Primary DI / UDI-DI
00887517058676
510(k) Number
FDA product code
PEK, KWP
GMDN term
Lumbar decompression interspinous spacer
Device class
Class II
Regulation number
888.3050
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Lumbar decompression interspinous spacer

Cleared under the same submission (K073278)

and 7 more cleared under K073278

Cleared under the same submission (K131238)

and 7 more cleared under K131238

Similar devices

Other devices filed under FDA product code PEK (Spinous process plate).

Other devices from NuVasive, LLC

  • CoRoent 6791713P2

    Class II

  • CoRoent 6791712P2

    Class II

  • ReLine 3800035

    Class II

  • ReLine 3800240

    Class II

See all devices from NuVasive, LLC →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
Other properties (10, all answered No)