Skip to content

Amp II 616-2-12-S

by Alphatec Spine, Inc.

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 Number00190376706870 UDI-DI Date18 Feb 2026ListedStatusListed 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  • Withdrawn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
Amp II
Generic Name
Spinal fixation plate, non-bioabsorbable
Model / Reference
616-2-12-S
Primary DI / UDI-DI
00190376706870
510(k) Number
FDA Product Code
OVD
GMDN Term
Spinal fixation plate, non-bioabsorbable
Device Class
Class II
Regulation Number
888.3080
GUDID distribution status
In Commercial Distribution
Size
Length — 33 Millimeter
Width — 11 Millimeter

Related devices

Cleared under the same submission (K242364)

Show all (12)

Other devices from Alphatec Spine, Inc.

See all devices from Alphatec Spine, Inc. →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (7)

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