Atlas Spine, Inc.
Atlas Spine, Inc. holds FDA 510(k) medical device clearances, first cleared 2007, most recent 2026, with 2 FDA device recalls on record.
Top product codes for Atlas Spine, Inc.
FDA recalls by Atlas Spine, Inc.
- Z-1616-2016 — Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into position
- Z-2274-2012 — Apelo Modular Screwdriver labeled in part: "APELO PEDICLE SCREW SYSTEM***Modular Screwdriver***Atlas Spine, Inc.***www.AtlasSpine.com*** 1555 Jupiter Park Drive #4***Jupiter, Florida 33458***561-741-1108***Tissue Sleeve***MFG Date: XX/XX/XXXX***Lot #: XXXX***Weldment***MFG Date: 03/23/2009***Sleeve Assembly***MFG Date: XX/XX/XXXX***Lot #: XXXX***Qty: 1 Rx Only***Non-Sterile. Sterilize Prior to Use*** Rev. A***. The Modular Screwdriver is used to insert modular pedicle screw implants which are part of the Apelo System.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Atlas Spine, Inc.
- K252822 — Atlas Spine HiRISE Expandable Cervical-p Corpectomy Implant
- K252560 — Atlas Spine HiRISE Expandable Cervical Corpectomy System
- K251969 — Atlas Spine Project X Expandable Posterior Lumbar Interbody System
- K243191 — Atlas Spine Lateral Expandable Interbody System
- K202302 — Atlas Spine Rebar (Ti) Spacer System
- K192570 — Atlas Spine Expandable Cervical Standalone Interbody System
- K182418 — V3 Segmental Plating System
- K180675 — Atlas Spine Expandable Cervical Interbody System
- K172334 — Ortus Expandable Lumbar Interbody Fusion System
- K162918 — Atlas Spine Expandable Interbody System
- K112759 — APCLO PEDICLE SCREW SYSTEMS
- K110842 — ATLAS SPINE PEDICLE SCREW SYSTEM
- K100743 — ATLAS SPINE PIVOTING SYSTEM
- K081880 — ATLAS SPINE SPACER
- K071497 — ATLAS SPINE VERTEBRAL BODY REPLACEMENT
- K063464 — ATLAS SPINE VERTEBRAL BODY REPLACEMENT
Data sourced from openFDA. This site is unofficial and independent of the FDA.