FDA.reportPublic FDA data

CURE OPEL-L

Primary DI
B16790044226T0
Brand
CURE OPEL-L
Company
MEDITECH SPINE, LLC
Model
900-442-26-T
Published
2022-10-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KWQAppliance, fixation, spinal intervertebral body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201136000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201136000Cure™ Lumbar Plate SystemMeditech Spine, LLC2020-05-12KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B16790044226T0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
182698477
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B167900002250CURE IVIEW9-00002-252022-10-07
B167900002260CURE IVIEW9-00002-262022-10-07
B167900002270CURE IVIEW9-00002-272022-10-07
B167900002280CURE IVIEW9-00002-282022-10-07
B167900002290CURE IVIEW9-00002-292022-10-07
B167900002300CURE IVIEW9-00002-302022-10-07
B167900002310CURE IVIEW9-00002-312022-10-07
B167900002320CURE IVIEW9-00002-322022-10-07
B167900002330CURE IVIEW9-00002-332022-10-07
B167900002340CURE IVIEW9-00002-342022-10-07
B167900002350CURE IVIEW9-00002-352022-10-07
B167900002360CURE IVIEW9-00002-362022-10-07
B167900002370CURE IVIEW9-00002-372022-10-07
B167900002380CURE IVIEW9-00002-382022-10-07
B167900002390CURE IVIEW9-00002-392022-10-07
B167900002400CURE IVIEW9-00002-402022-10-07
B167900002410CURE IVIEW9-00002-412022-10-07
B167900002420CURE IVIEW9-00002-422022-10-07
B167900002430CURE IVIEW9-00002-432022-10-07
B167900002440CURE IVIEW9-00002-442022-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810017916450Saber-CELEVATION SPINE, INC.KWQ2026-07-07
00810017916467Saber-CELEVATION SPINE, INC.KWQ2026-07-07
00810017916474Saber-CELEVATION SPINE, INC.KWQ2026-07-07
00810017916481Saber-CELEVATION SPINE, INC.KWQ2026-07-07
00810017916498Saber-CELEVATION SPINE, INC.KWQ2026-07-07
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-06-28
00810017913893Saber-C Body (PT), 14x17x6 6 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017913909Saber-C Body (PT), 14x17x7 6 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017913916Saber-C Body (PT), 14x17x8 6 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017913923Saber-C Body (PT), 14x17x9 6 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017914357Saber-C Plate, 12x15x5 12 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017914364Saber-C Plate, 12x15x6 12 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017914371Saber-C Plate, 12x15x7 12 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017914388Saber-C Plate, 12x15x8 12 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017914395Saber-C Plate, 12x15x9 12 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017914401Saber-C Plate, 12x15x10 12 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017914630Saber-C Plate, 14x17x9 12 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00193982572983CREOGLOBUS MEDICAL, INC.KWQ2026-06-10
00840493423531RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-10
00840493423548RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-10
00840493423555RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-10
00841732150911PREFERENCE Pedicle Screw SystemCTL Medical CorporationKWQ2023-09-09
00841732150928PREFERENCE Pedicle Screw SystemCTL Medical CorporationKWQ2023-09-09
B6785211900PreView II™NEXUS SPINE, L.L.C.KWQ2021-12-17
B6785211910PreView II™NEXUS SPINE, L.L.C.KWQ2021-12-17
10889981142117MarinerSeaspine Orthopedics CorporationKWQ2021-10-02
10889981142124MarinerSeaspine Orthopedics CorporationKWQ2021-10-02
10889981142148MarinerSeaspine Orthopedics CorporationKWQ2021-10-02
10889981142155MarinerSeaspine Orthopedics CorporationKWQ2021-10-02
10889981142179MarinerSeaspine Orthopedics CorporationKWQ2021-10-02