FDA.reportPublic FDA data

Slimplicity Anterior Cervical Plate System

Primary DI
00815362021385
Brand
Slimplicity Anterior Cervical Plate System
Company
PRECISION SPINE, INC.
Model
08-9003
Catalog number
08-9003
Device description
Bone Tap
Published
2019-03-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HWXTap, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWXTap, BoneOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815362021385PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815362021385008153620213858153620213850815362021385

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation implant/sterilization container setA collection of non-sterile, implantable components of an internal spinal fixation assembly (e.g., plates, rods, screws, connectors, and/or hooks) packaged within a reusable sterilization container (i.e., all under the same product code) to be sterilized prior to implantation. The set provides the surgeon with a selection of implants (e.g., different sizes) during surgery, whereby unused implants may be resterilised for subsequent implantation in another patient. Instruments intended to facilitate implantation may be packaged with the set. This is a reusable device which includes single-use implants.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
079398589
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840019904650Slimplicity Anterior Cervical Plate SystemACP118ACP1182019-04-11
00840019904667Slimplicity Anterior Cervical Plate SystemACP120ACP1202019-04-11
00840019904674Slimplicity Anterior Cervical Plate SystemACP122ACP1222019-04-11
00840019904681Slimplicity Anterior Cervical Plate SystemACP124ACP1242019-04-11
00840019904698Slimplicity Anterior Cervical Plate SystemACP126ACP1262019-04-11
00840019904704Slimplicity Anterior Cervical Plate SystemACP128ACP1282019-04-11
00815362021446Slimplicity Anterior Cervical Plate System08-902008-90202019-04-01
00815362021453Slimplicity Anterior Cervical Plate System08-902108-90212019-04-01
00815362021460Slimplicity Anterior Cervical Plate System08-902408-90242019-04-01
00815362021477Slimplicity Anterior Cervical Plate System08-902508-90252019-04-01
00815362021484Slimplicity Anterior Cervical Plate System08-902608-90262019-04-01
00815362021729Slimplicity Anterior Cervical Plate System50-001850-00182019-04-01
00815362021088Slimplicity Anterior Cervical Plate System08-011208-01122019-03-29
00815362021118Slimplicity Anterior Cervical Plate System08-011808-01182019-03-29
00815362021125Slimplicity Anterior Cervical Plate System08-012008-01202019-03-29
00815362021132Slimplicity Anterior Cervical Plate System08-012208-01222019-03-29
00815362021149Slimplicity Anterior Cervical Plate System08-012408-01242019-03-29
00815362021156Slimplicity Anterior Cervical Plate System08-012608-01262019-03-29
00815362021163Slimplicity Anterior Cervical Plate System08-012808-01282019-03-29
00815362021170Slimplicity Anterior Cervical Plate System08-022608-02262019-03-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290019361343OSSIO® TapOSSIO LTDHWX2026-07-19
07290019361350OSSIO® TapOSSIO LTDHWX2026-07-19
07290019361367OSSIO® TapOSSIO LTDHWX2026-07-19
07290019361374OSSIO® TapOSSIO LTDHWX2026-07-19
07290019361381OSSIO® TapOSSIO LTDHWX2026-07-19
18257200076581CETRAOrthofix US LLCHWX2026-07-17
18257200076604CETRAOrthofix US LLCHWX2026-07-17
18257200076611CETRAOrthofix US LLCHWX2026-07-17
18257200076628CETRAOrthofix US LLCHWX2026-07-17
09120125220280Shark Screw® tapsurgebright GmbHHWX2026-04-30
10705034577913N/AMedos International SàrlHWX2026-04-23
10705034577920N/AMedos International SàrlHWX2026-04-23
10705034577937N/AMedos International SàrlHWX2026-04-23
10705034577944N/AMedos International SàrlHWX2026-04-23
10705034577951N/AMedos International SàrlHWX2026-04-23
10705034577968N/AMedos International SàrlHWX2026-04-23
10705034577975N/AMedos International SàrlHWX2026-04-23
10705034577982N/AMedos International SàrlHWX2026-04-23
10705034577999N/AMedos International SàrlHWX2026-04-23
G079C5020000950Golden Isles Pedicle Screw SystemIntelivation, LLCHWX2026-04-22
G079C5020001000Golden Isles Pedicle Screw SystemIntelivation, LLCHWX2026-04-22
G079C5020001050Golden Isles Pedicle Screw SystemIntelivation, LLCHWX2026-04-22
08800322758182Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HWX2026-04-21
08800322758199Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HWX2026-04-21
08800322758205Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HWX2026-04-21
08800322758212Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HWX2026-04-21
08800322758229Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HWX2026-04-21
08800322758243Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HWX2026-04-21
08800322758250Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HWX2026-04-21
08800322758281Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HWX2026-04-21