Product code OWI— Orthopedic

“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.”

FDA has cleared 37 devices under product code OWI between 2011 and 2026, filed by 20 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20262 clearances
• 20232 clearances
• 20221 clearance
• 20211 clearance
• 20203 clearances
• 20193 clearances
• 20184 clearances
• 20177 clearances
• 20165 clearances
• 20153 clearances
• 20143 clearances
• 20132 clearances
• 20111 clearance

• Implanet, S.A.7 clearances
• Medicrea International SA4 clearances
• K2m, Inc.3 clearances
• Globus Medical, Inc.3 clearances
• Spinal Elements, Inc.2 clearances
• OrthoPediatrics Corp.2 clearances
• Nu Vasive, Incorporated2 clearances
• Cousin Biotech Sas2 clearances
• Zimmer Spine, Inc.1 clearance
• Zimmer Spine1 clearance

• K261374 — LigaPASS SystemMedicrea International S.A.S·2026-05-27
• K253615 — Invictus Bands SystemAlphatec Spine, Inc.·2026-03-25
• K222097 — OLYMPIC Deformity Band SystemAstura Medical·2023-05-04
• K230565 — HILINE Fixation SystemGlobus Medical, Inc.·2023-04-20
• K213659 — LigaPASS 2.0 Ligament Augmentation SystemMedicrea International SA·2022-05-24
• K211057 — LigaPASS® Spinal System, CD Horizon Spinal SystemMedtronic, Inc.·2021-05-27
• K201240 — Mariner Cap SystemSeaSpine Orthopedics Corporation·2020-08-05
• K200281 — The Gecko Spinal SystemOrtho Development Corporation·2020-03-31
• K200097 — Response BandLoc Spinal FixationOrthoPediatrics Corp.·2020-03-16
• K191217 — JAZZ PFImplanet, S.A.·2019-08-02
• K190289 — Karma® Fixation SystemSpinal Elements, Inc.·2019-04-03
• K190418 — NuVasive® VersaTie® SystemNu Vasive, Incorporated·2019-03-21
• K180728 — Spinal Elements Cerclage SystemSpinal Elements, Inc.·2018-09-06
• K181799 — ResCUBE Ligament Fixation SystemCousin Biotech Sas·2018-08-29
• K172206 — NAJA Ligament Correction SystemCousin Biotech Sas·2018-04-10
• K173506 — LigaPASSMedicrea International SA·2018-04-03
• K173117 — NuVasive® VersaTie SystemNuvasive, Inc.·2017-12-07
• K172417 — SILC® Fixation SystemGlobus Medical, Inc.·2017-10-26
• K172021 — LigaPASSMedicrea International SA·2017-08-30
• K171881 — JAZZ Passer BandImplanet, S.A.·2017-08-08
• K170730 — JAZZ System, including JAZZ BandImplanet, S.A.·2017-06-09
• K163181 — TRANSLACE Spinal Tethering SystemMedtronic Sofamor Danek USA, Inc.·2017-05-16
• K161332 — NILE Proximal Fixation Spinal SystemK2m, Inc.·2017-04-05
• K160698 — LigaPASSMedicrea International SA·2016-09-02
• K161267 — Response BandLoc Spinal FixationOrthoPediatrics Corp.·2016-08-11
• K161265 — NuVasive® VersaTie SystemNu Vasive, Incorporated·2016-07-15
• K153348 — JAZZ LOCKImplanet, S.A.·2016-03-31
• K160208 — NILE Alternative Fixation Spinal SystemK2m, Inc.·2016-03-18
• K151740 — JAZZ SystemImplanet, S.A.·2015-08-27
• K143759 — JAZZ SystemImplanet, S.A.·2015-05-07
• K143350 — Nile Alternative FixationK2m, Inc.·2015-02-25
• K142053 — UNIVERSAL CLAMP SPINAL FIXATION SYSTEMZimmer Spine, Inc.·2014-10-29
• K133482 — SILC FIXATION SYSTEMGlobus Medical, Inc.·2014-05-21
• K133617 — JAZZ SYSTEMImplanet, S.A.·2014-02-20
• K132395 — LIGAPASSMedicrea International·2013-12-06
• K132287 — JAZZ SYSTEMHogan Lovells US LLP·2013-09-25
• K110348 — UNIVERSAL CLAMP SPINAL FIXATION SYSTEMZimmer Spine·2011-08-11