Atlas FDA

OWI

37 FDA 510(k) clearances · Product code

89 daysmedian time to decision
189 days90th percentile
37clearances measured

FDA profile

Official device name
Bone Fixation Cerclage, Sublaminar
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3010
Medical specialty
Orthopedic
Flags
Implant
FDA definition
Acts as a bone anchor for temporary stabilization, or used in conjunction with other medical implants of similar metals when wiring is needed, during development of a spinal fusion.
Adverse events (MAUDE)
2019: 13
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
LigaPASS™ System (K261374)Medicrea International S.A.S2026-05-27
Invictus Bands System (K253615)Alphatec Spine, Inc.2026-03-25
OLYMPIC Deformity Band System (K222097)Astura Medical2023-05-04
HILINE™ Fixation System (K230565)Globus Medical, Inc.2023-04-20
LigaPASS™ 2.0 Ligament Augmentation System (K213659)Medicrea International SA2022-05-24
LigaPASS® Spinal System, CD Horizon™ Spinal System (K211057)Medtronic, Inc.2021-05-27
Mariner Cap System (K201240)SeaSpine Orthopedics Corporation2020-08-05
The Gecko Spinal System (K200281)Ortho Development Corporation2020-03-31
Response BandLoc Spinal Fixation (K200097)OrthoPediatrics Corp.2020-03-16
JAZZ PF (K191217)Implanet, S.A.2019-08-02
Karma® Fixation System (K190289)Spinal Elements, Inc.2019-04-03
NuVasive® VersaTie® System (K190418)Nu Vasive, Incorporated2019-03-21
Spinal Elements Cerclage System (K180728)Spinal Elements, Inc.2018-09-06
ResCUBE™ Ligament Fixation System (K181799)Cousin Biotech Sas2018-08-29
NAJA™ Ligament Correction System (K172206)Cousin Biotech Sas2018-04-10
LigaPASS (K173506)Medicrea International SA2018-04-03
NuVasive® VersaTie™ System (K173117)Nuvasive, Inc.2017-12-07
SILC® Fixation System (K172417)Globus Medical, Inc.2017-10-26
LigaPASS (K172021)Medicrea International SA2017-08-30
JAZZ Passer Band (K171881)Implanet, S.A.2017-08-08
JAZZ System, including JAZZ Band (K170730)Implanet, S.A.2017-06-09
TRANSLACE™ Spinal Tethering System (K163181)Medtronic Sofamor Danek USA, Inc.2017-05-16
NILE Proximal Fixation Spinal System (K161332)K2m, Inc.2017-04-05
LigaPASS (K160698)Medicrea International SA2016-09-02
Response BandLoc Spinal Fixation (K161267)OrthoPediatrics Corp.2016-08-11
NuVasive® VersaTie System (K161265)Nu Vasive, Incorporated2016-07-15
JAZZ LOCK (K153348)Implanet, S.A.2016-03-31
NILE Alternative Fixation Spinal System (K160208)K2m, Inc.2016-03-18
JAZZ System (K151740)Implanet, S.A.2015-08-27
JAZZ System (K143759)Implanet, S.A.2015-05-07
Nile Alternative Fixation (K143350)K2m, Inc.2015-02-25
UNIVERSAL CLAMP SPINAL FIXATION SYSTEM (K142053)Zimmer Spine, Inc.2014-10-29
SILC FIXATION SYSTEM (K133482)Globus Medical, Inc.2014-05-21
JAZZ SYSTEM (K133617)Implanet, S.A.2014-02-20
LIGAPASS (K132395)Medicrea International2013-12-06
JAZZ SYSTEM (K132287)Hogan Lovells US LLP2013-09-25
UNIVERSAL CLAMP SPINAL FIXATION SYSTEM (K110348)Zimmer Spine2011-08-11

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