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11 devices found
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Manufacturer: Empirical Spine, Inc.
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Device · Manufacturer · Authorizations
Verified
Status
Regime
Registry
Class
Limiflex Dynamic Sagittal Tether Gen 3
Empirical Spine, Inc.
·
,
FDA registration: United States
Class III
GUDID
on market
None
GUDID
III
Limiflex Dynamic Sagittal Tether Instrument Set Gen 3
Empirical Spine, Inc.
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Passer Gen 3
Empirical Spine, Inc.
·
,
FDA registration: United States
Class I
GUDID
on market
None
GUDID
I
Holder Gen 3
Empirical Spine, Inc.
·
,
FDA registration: United States
Class I
GUDID
on market
None
GUDID
I
Symbol Plate Gen 3
Empirical Spine, Inc.
·
,
FDA registration: United States
Class I
GUDID
on market
None
GUDID
I
Driver Gen 3
Empirical Spine, Inc.
·
,
FDA registration: United States
Class I
GUDID
on market
None
GUDID
I
Tensioner Clip Gen 3
Empirical Spine, Inc.
·
,
FDA registration: United States
Class I
GUDID
on market
None
GUDID
I
Instrument Tray Gen 3
Empirical Spine, Inc.
·
,
FDA registration: United States
Class II
GUDID
on market
None
GUDID
II
Tensioner Gen 3
Empirical Spine, Inc.
·
,
FDA registration: United States
Class I
GUDID
on market
None
GUDID
I
LimiFlex® Dynamic Sagittal Tether Instrument Set
Empirical Spine, Inc.
·
,
FDA registration: United States
Class II
FDA 510(k)
K253374
Active
Cleared 16 Jun 2026
Active
510(k)
510(k)
II
LimiFlex Dynamic Sagittal Tether
Empirical Spine, Inc.
·
,
FDA registration: United States
Class III
FDA PMA
P220031
Active
Approved 12 Feb 2026
Active
PMA
PMA
III
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