FDA.reportPublic FDA data

HTR-PMI

Primary DI
00841036244262
Brand
HTR-PMI
Company
BIOMET MICROFIXATION, INC
Model
PM620319
Published
2018-01-11
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FWPProsthesis, Chin, Internal
FZEProsthesis, Nose, Internal
KKYMaterial, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
LZKImplant, Malar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FWPProsthesis, Chin, InternalGeneral, Plastic Surgery2
FZEProsthesis, Nose, InternalGeneral, Plastic Surgery2
KKYMaterial, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial ReconstructionGeneral, Plastic Surgery2
LZKImplant, MalarGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K924935000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K924935000HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANTPolyclinic Medical Center1993-09-02KKY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841036244262PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841036244262008410362442628410362442620841036244262

GMDN Terms#

Term, Definition table
TermDefinition
Cranioplasty plate, non-alterableAn implantable shield designed to repair larger skull defects that is preformed before surgery and typically made of sheets of material [e.g., stainless steel, vitallium, titanium (Ti), plastic resins] that cannot be reshaped at the time of surgery without changing the physical or chemical properties of the material. The device is generally preformed with a central convex curvature matching the curvature of the forehead, side, or rear areas of the human adult skull; it is usually fixed to the intact cranial bones using screws and/or other fasteners. The device is used to repair defects due to injury, surgical intervention for tumour removal, congenital anomaly, or disease.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at Room Temperature. Avoid prolonged exposure to elevated temperature.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(904)741-4400FXJAX-ORDERS@ZIMMERBIOMET.COM

Regulatory Flags#

DUNS number
046189866
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888233085021PECTUS BLU (TM)78-820078-82002026-01-27
00888233085038PECTUS BLU (TM)78-825078-82502026-01-27
00810128536875PECTUS BLU (TM)78-850078-85002024-09-30
00888233077170PECTUS BLU (TM)78-800078-80002024-09-30
00888233077187PECTUS BLU (TM)78-808078-80802024-09-30
00888233077194PECTUS BLU (TM)78-808178-80812024-09-30
00888233077200PECTUS BLU (TM)78-808278-80822024-09-30
00888233077224PECTUS BLU (TM)78-830078-83002024-09-30
00888233077231PECTUS BLU (TM)78-835078-83502024-09-30
00888233077248PECTUS BLU (TM)78-840078-84002024-09-30
00888233077255PECTUS BLU (TM)78-845078-84502024-09-30
00888233077279PECTUS BLU (TM)78-855078-85502024-09-30
00888233028776PECTUS BLU (TM)78-001078-00102022-02-09
00888233028783PECTUS BLU (TM)78-001178-00112022-02-09
00888233028790PECTUS BLU (TM)78-001278-00122022-02-09
00888233028806PECTUS BLU (TM)78-002078-00202022-02-09
00888233028813PECTUS BLU (TM)78-003078-00302022-02-09
00888233028837PECTUS BLU (TM)78-004078-00402022-02-09
00888233028844PECTUS BLU (TM)78-005078-00502022-02-09
00888233028851PECTUS BLU (TM)78-005178-00512022-02-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327300536MEDPORStryker Leibinger GmbH & Co. KGFWP2023-02-13
07613327300406MEDPORStryker Leibinger GmbH & Co. KGFWP2023-01-09
07613327300413MEDPORStryker Leibinger GmbH & Co. KGFWP2023-01-09
07613327300437MEDPORStryker Leibinger GmbH & Co. KGFWP2023-01-09
07613327300444MEDPORStryker Leibinger GmbH & Co. KGFWP2023-01-09
07613327300451MEDPORStryker Leibinger GmbH & Co. KGFWP2023-01-09
07613327300475MEDPORStryker Leibinger GmbH & Co. KGFWP2023-01-09
07613327300499MEDPORStryker Leibinger GmbH & Co. KGFWP2023-01-09
07613327300505MEDPORStryker Leibinger GmbH & Co. KGFWP2023-01-09
07613327300512MEDPORStryker Leibinger GmbH & Co. KGFWP2023-01-09
07613327300529MEDPORStryker Leibinger GmbH & Co. KGFWP2023-01-09
07613327300550MEDPORStryker Leibinger GmbH & Co. KGFWP2023-01-09
07613327300567MEDPORStryker Leibinger GmbH & Co. KGFWP2023-01-09
07613327480245MEDPORStryker Leibinger GmbH & Co. KGFWP2019-09-20
M724ACSIZNS1Anatomical Chin SizersIMPLANTECH ASSOCIATES, INC.FWP2017-10-17
M724BSMIISIZNS1Binder Submalar® II SizerIMPLANTECH ASSOCIATES, INC.LZK2017-10-17
M724BSMSIZNS1Binder Submalar® SizerIMPLANTECH ASSOCIATES, INC.LZK2017-10-17
M724CBSMSIZNS1Conform Binder Submalar® SizersIMPLANTECH ASSOCIATES, INC.LZK2017-10-17
M724CCSMSIZNS1Conform Midfacial Implant SizersIMPLANTECH ASSOCIATES, INC.LZK2017-10-17
M724CEACSIZNS1Conform™ Extended AnatomicalIMPLANTECH ASSOCIATES, INC.FWP2017-10-17
M724CMASIZNS1Conform Mandibular Angle™ SizersIMPLANTECH ASSOCIATES, INC.LZK2017-10-17
M724CSCSIZNS1Curvilinear Silicone Chin SizersIMPLANTECH ASSOCIATES, INC.FWP2017-10-17
M724CSMSIZNS1Combined Submalar Shell™ SizersIMPLANTECH ASSOCIATES, INC.LZK2017-10-17
M724CTMSSIZNS1Conform Terino Malar Shell® IMPLANTECH ASSOCIATES, INC.LZK2017-10-17
M724EACSIZNS1Extended Anatomical Chin SizersIMPLANTECH ASSOCIATES, INC.FWP2017-10-17
M724FMGVSIZNS1Flowers Mandibular Glove® Sizers IMPLANTECH ASSOCIATES, INC.FWP2017-10-17
M724FTTSIZNS1Flowers Tear Trough® SizersIMPLANTECH ASSOCIATES, INC.LZK2017-10-17
M724MPJSIZNS1Mandibular Pre Jowl® ImplantIMPLANTECH ASSOCIATES, INC.FWP2017-10-17
M724TEACSIZNS1Terino Extended Anatomical™IMPLANTECH ASSOCIATES, INC.FWP2017-10-17
09321502015615BahaCochlear Bone Anchored Solutions ABFZE2017-06-07