510(k) clearances

Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX Interbody System

Alphatec Spine, Inc. · Orthopedic

K262646Substantially EquivalentTraditionalMAX
Open FDA's page for this record
Third party flag
N
City
Carlsbad
Advisory committee description
Orthopedic
Address 1
1950 Camino Vida Roble
Statement or summary
Summary
Product code
MAX
Zip code
92008
Applicant
Alphatec Spine, Inc.
Decision date
2026-10-21
Decision code
SESE
Country code
US
Device name
Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX Interbody System
Advisory committee
OR
Contact
Griffin Riggs
K number
K262646
State
CA
Date received
2026-07-30
Review advisory committee
OR
Postal code
92008
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Intervertebral Fusion Device With Bone Graft, Lumbar
Medical specialty description
Orthopedic
Regulation number
888.3080
Device class
2
Registration number
9617297, 3007604895, 1226544, 8010273, 3007993775, 3007485169, 3008864603, 3006846753, 3016099068, 3010866843, 3017065977, 1000493591, 3009554293, 3005819474, 9615766, 3006563559, 3033739814, 3017780544, 3043543260, 3010375065, 3010370880, 3010646402, 2531477, 3013514648, 3036756245, 3013546462, 3010039400, 3016460869, 3011127597, 1828288, 1219655, 3011556898, 3015941638, 3005751028, 3024999441, 3009756327, 3016112537, 3009882462, 2133687, 3008526708 +393 more
FEI number
3000718490, 3007604895, 3007993775, 1000139987, 1000069183, 3007485169, 3008864603, 3006846753, 3016099068, 1000143502, 3010866843, 3003690049, 3017065977, 1000493591, 3009554293, 3005819474, 3006563559, 3003112432, 3033739814, 3017780544, 3043543260, 3010375065, 3010370880, 3010646402, 3013514648, 3036756245, 3013546462, 3010039400, 3003142829, 3011127597, 1828288, 3016460869, 1219655, 3011556898, 3005751028, 3024999441, 3016112537, 3009882462, 3008526708, 1000514656 +393 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.