FDA.reportPublic FDA data

Titanium Hip Plate

Primary DI
00813892020595
Brand
Titanium Hip Plate
Company
Orthopedic Sciences Inc
Model
TS-055
Catalog number
TS-055
Device description
55mm Titanium Compression Screw
Published
2015-10-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRSPLATE, FIXATION, BONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072175000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072175000TITANIUM HIP TOOL LOCKING PLATEOrthopedic Sciences, Inc.2007-08-21HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813892020595PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813892020595008138920205958138920205950813892020595

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, sterileA small, sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). There are a number of kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression across bone fragments.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length55Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep at room temperature
Storage Environment Temperature0 Degrees Fahrenheit122 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(562)799-5550info@orthopedicsciences.com

Regulatory Flags#

DUNS number
068109169
Device count
1
DM exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813892020779Outologous Spinal Fixation SystemPS6030PS60302015-10-13
00813892020786Outologous Spinal Fixation SystemPS6035PS60352015-10-13
00813892020793Outologous Spinal Fixation SystemPS6040PS60402015-10-13
00813892020809Outologous Spinal Fixation SystemPS6045PS60452015-10-13
00813892020816Outologous Spinal Fixation SystemPS6050PS60502015-10-13
00813892020823Outologous Spinal Fixation SystemPS6055PS60552015-10-13
00813892020830Outologous Spinal Fixation SystemPS6060PS60602015-10-13
00813892020847Outologous Spinal Fixation SystemPS7030PS70302015-10-13
00813892020854Outologous Spinal Fixation SystemPS7035PS70352015-10-13
00813892020861Outologous Spinal Fixation SystemPS7040PS70402015-10-13
00813892020878Outologous Spinal Fixation SystemPS7045PS70452015-10-13
00813892020885Outologous Spinal Fixation SystemPS7050PS70502015-10-13
00813892020892Outologous Spinal Fixation SystemPS7055PS70552015-10-13
00813892020908Outologous Spinal Fixation SystemPS7060PS70602015-10-13
00813892020915Outologous Spinal Fixation SystemRD6040RD60402015-10-13
00813892020922Outologous Spinal Fixation SystemRD6050RD60502015-10-13
00813892020939Outologous Spinal Fixation SystemRD6060RD60602015-10-13
00813892020946Outologous Spinal Fixation SystemRD6070RD60702015-10-13
00813892020953Outologous Spinal Fixation SystemRD6080RD60802015-10-13
00813892020960Outologous Spinal Fixation SystemRD6090RD60902015-10-13

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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03700569658199Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569662202Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663247Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663841Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663865Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663872Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663889Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663896Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663902Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663919Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663926Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663933Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663940Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663964Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569671327Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569676438Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569676445Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569676452Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569676469Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
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