FDA.reportPublic FDA data

CURE ACP

Primary DI
B167S1700430140
Brand
CURE ACP
Company
MEDITECH SPINE, LLC
Model
S1-700-430-14
Published
2017-10-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
K160604000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160604000Cure™ Anterior Cervical Plate (ACP) SystemMeditech Spine, LLC2016-07-01KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B167S1700430140PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Fluted surgical drill bit, single-use, sterileA sterile shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is mounted into a surgical power tool or a surgical hand drill/brace. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
182698477
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
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
00810017915125SABER-XA, Screw Ø5.0 x 22.5ELEVATION SPINE, INC.KWQ2026-09-22
00810017915149SABER-XA, Screw Ø5.0 x 32.5ELEVATION SPINE, INC.KWQ2026-09-22
00810017915156SABER-XA, Screw Ø5.5 x 22.5ELEVATION SPINE, INC.KWQ2026-09-22
00810017915163SABER-XA, Screw Ø5.5 x 27.5ELEVATION SPINE, INC.KWQ2026-09-22
00810017915170SABER-XA, Screw Ø5.5 x 32.5ELEVATION SPINE, INC.KWQ2026-09-22
10888857598164Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598171Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598188Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598195Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598201Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598218Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598225Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598232Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598249Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
00810056993146corraCarlsmed, Inc.KWQ2026-01-30
00613994568311TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2015-08-05
00613994568823TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2015-08-05
04546540147257XIA IIStryker CorporationKWQ2014-12-08
04546540147769XIA IIStryker CorporationKWQ2014-12-08
04546540147806XIA IIStryker CorporationKWQ2014-12-08
04546540147905XIA IIStryker CorporationKWQ2014-12-08
04546540147912XIA IStryker CorporationKWQ2014-12-08
04546540147929XIA IStryker CorporationKWQ2014-12-08
04546540147936XIA IStryker CorporationKWQ2014-12-08
04546540147974XIA IStryker CorporationKWQ2014-12-08
04546540147981XIA IStryker CorporationKWQ2014-12-08
04546540147998XIA IStryker CorporationKWQ2014-12-08
04546540148001XIA IIStryker CorporationKWQ2014-12-08
04546540148018XIA IIStryker CorporationKWQ2014-12-08
04546540148025XIA IIStryker CorporationKWQ2014-12-08