Skip to content

APEX Spine System PF6-5530

by Spinecraft LLC 2 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00193082015007 UDI-DI Date25 Mar 2019ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
APEX Spine System
Generic Name
Spinal bone screw, non-bioabsorbable
Model / Ref / Catalog
PF6-5530
Description
APEX Ti Poly Screw Dia.5.50, 30mm, Self-Tapping
Primary DI / UDI-DI
00193082015007
510(k) Number
FDA Product Code
KWQ, MNI, MNH, NKB, KWP
GMDN Term
Spinal bone screw, non-bioabsorbable
Device Class
Class II
Regulation Number
888.3060, 888.3070, 888.3050
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Spinal bone screw, non-bioabsorbable

Cleared under the same submission (K062513)

Show all (12)

Cleared under the same submission (K092825)

Show all (12)

Cleared under the same submission (K102488)

Show all (12)

Cleared under the same submission (K110906)

Show all (12)

Cleared under the same submission (K132603)

Show all (12)

Other devices from Spinecraft LLC

See all devices from Spinecraft LLC →

Properties

  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number

Other properties (10)

  • Sterile: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No