510(k) clearances

Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System

Spectrum Spine · Orthopedic

K252240Substantially EquivalentTraditionalODP
Open FDA's page for this record
Third party flag
N
City
Jasper
Advisory committee description
Orthopedic
Address 1
20 Harmony Ct.
Statement or summary
Summary
Product code
ODP
Zip code
30143
Applicant
Spectrum Spine
Decision date
2026-03-30
Decision code
SESE
Country code
US
Device name
Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System
Advisory committee
OR
Contact
James Robinson
K number
K252240
State
GA
Date received
2025-07-17
Review advisory committee
OR
Postal code
30143
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Intervertebral Fusion Device With Bone Graft, Cervical
Medical specialty description
Orthopedic
Regulation number
888.3080
Device class
2
Registration number
3010123206, 3003525643, 1824199, 9615128, 3013055499, 3010370500, 3017936978, 3006563559, 3008114965, 8010273, 3021945817, 3006082533, 1000432246, 3006487372, 3009129735, 3005751028, 3023138345, 1225492, 3010120104, 2953359, 1000461041, 3011181154, 1529009, 8043792, 3014680795, 3005061536, 1834331, 3014967552, 3042175940, 3005677016, 3010326971, 3009756327, 3009973505, 2530808, 3025602479, 3015991317, 3013462427, 3016050940, 1047843, 3006128100 +312 more
FEI number
3010123206, 3003525643, 1824199, 3013055499, 3010370500, 3017936978, 3006563559, 3008114965, 3021945817, 3006082533, 1000432246, 3006487372, 3009129735, 3005751028, 3023138345, 3010120104, 1000461041, 1000518731, 3011181154, 3014680795, 3005061536, 3014967552, 3002980729, 3042175940, 3005677016, 3010326971, 3009973505, 3025602479, 3015991317, 3002806773, 3002807038, 3013462427, 3016050940, 1047843, 3006128100, 3007993775, 3009144915, 3036496433, 3005180920, 3000205591 +312 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.