# Alphatec Mfg., Inc.

- Location (FDA's records): Palm Desert, CA
- FDA decisions: 20 (1990–2004): 20 510(k) clearances
- Product codes: HRS (4), HWC (4), KWP (3), KTT (3), MNH (1), JDW (1), MNI (1), JEC (1), KWQ (1), HSB (1)
- Predicates its devices cite: 8 (3 its own); citations of its devices by later devices: 29 (3 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Sofamor Danek USA,Inc.: 1 (https://510kreport.com/company/sofamor-danek-usa)
- U&I Corp., America: 1 (https://510kreport.com/company/u-i-america)
- D.K.M. Co., Ltd.: 1 (https://510kreport.com/company/dkm)
- Depuy, Inc.: 1 (https://510kreport.com/company/depuy)
- Synthes (Usa): 1 (https://510kreport.com/company/synthes-usa)

## Firms that cite its devices most
- Alphatec Spine, Inc.: 7 (https://510kreport.com/company/alphatec-spine)
- Aesculap, Inc.: 3 (https://510kreport.com/company/aesculap)
- Ferguson Medical: 3 (https://510kreport.com/company/ferguson-medical)
- Biomet Orthopedics, Inc.: 2 (https://510kreport.com/company/biomet-orthopedics)
- Dolphin Medical Technologies, Inc.: 2 (https://510kreport.com/company/dolphin-medical-technologies)
- Kinetikos Medical, Inc.: 2 (https://510kreport.com/company/kinetikos-medical)
- Scien'Tx USA, Inc.: 2 (https://510kreport.com/company/scien-tx-usa)
- Kalitec Direct, LLC: 1 (https://510kreport.com/company/kalitec-direct)

## Its most-cited devices
- K033090: Icon Polyaxial Pedicle Screw System (2004), cited by 10
- K951846: Mirage Spinal System for Severe Spondylolisthesis (1996), cited by 6
- K921622: Alphatec Compression Hip Screw System (1992), cited by 5
- K933112: Alphatec Compression and Reconstruction Plates (1994), cited by 1
- K914004: Alphatec Cannulated Bone Screws (1991), cited by 1
- K020356: Alpha Mirage Top Tightening Spinal System (2002), cited by 1

## Recent decisions
- K033090: Icon Polyaxial Pedicle Screw System (Mar 26, 2004)
- K023299: Alpha Mirage Top Tightening Spinal System (Dec 11, 2002)
- K020356: Alpha Mirage Top Tightening Spinal System (Jul 23, 2002)
- K993513: Deltaloc Anterior Cervical Plate System (Apr 26, 2000)
- K993873: Alphatec External Fixation System Compression/Distraction Rod (Jan 3, 2000)
- K992350: Pylon Intramedullaary Nail System (Sep 22, 1999)
- K980788: Alphatec Wire External Fixation System (May 22, 1998)
- K964400: Alphatec External Fixation System (Apr 28, 1997)

Source page: https://510kreport.com/company/alphatec-mfg