FDA.report

Micro Seal Anatomic 10 Degree Liner

Primary DI
B046WB110820
Brand
Micro Seal Anatomic 10 Degree Liner
Company
SIGNAL MEDICAL CORPORATION
Model
32x58x10
Catalog number
WB-1-1082
Device description
Micro Seal Anatomic 10 Degree Liner 32x58
Published
2017-08-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Product Code Classifications

CodeDeviceSpecialtyClass
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2

Premarket Submissions

SubmissionSupplement
K955271000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K955271000MICRO-SEAL ACETABULAR SYSTEMWhiteside Instruments1996-01-30LPH

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B046WB110820PrimaryHIBCC0

GMDN Terms

TermDefinition
Femoral head bipolar componentA sterile implantable hemisphere-shaped device used as part of a partial hip replacement (femoral) and designed to interface with the acetabulum on its outer surface where it freely rotates, and interface with a femoral head prosthesis on its inner surface where it allows free rotation of the head. It is a one-piece device typically composed of an outer metal shell (e.g., titanium alloy) and an inner polyethylene (PE) liner; it is typically used for older femoral fracture patients.

Sterilization Methods

Method

Contacts

PhoneEmail
810-364-7070vfowler@signalmd.com

Regulatory Flags

DUNS number
169289308
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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B046BIO110930Straight Osteotome1/2"BIO-1-10932023-04-24
B046BIO110440Knee OsteogatorN/ABIO-1-10442023-03-14
B046BIO110830PCL RetractorN/ABIO-1-10832023-02-21
B046BIO11081Femoral BeltN/ABIO-1-10812022-06-17
B046BIO110430Alligator Rongeur9"BIO-1-10432022-05-12
B046BIO11082Tibial BeltN/ABIO-1-10822022-05-12
B046BIO110840Lateral RetractorN/ABIO-1-10842022-05-12
B046BIO110910Mallet Tip - TeflonTeflonBIO-1-10912022-03-24
B046BIO110350Gel Pad46"BIO-1-10352022-02-10
B046BIO110410Alligator Rongeur5"BIO-1-10412021-12-02
B046BIO110420Alligator Rongeur7"BIO-1-10422021-12-02
B046BIO110210Slide BlockBIO-1-1021BIO-1-10212021-10-22
B046BIO110220Boot AssemblyBIO-1-1022BIO-1-10222021-10-22
B046BIO110240End StopBIO-1-1024BIO-1-10242021-10-22
B046BIO110900Soft Face Mallet750 gramBIO-1-10902021-10-15
B046BIO11012A0Low Profile Cable1.5mm CableBIO-1-1012-A2021-08-26
B046220811101500Coated Revision Stem10x15022-08-11101502021-08-18
B046220811221000Coated Revision Stem22x10022-08-11221002021-08-18
B046220811241000Coated Revision Stem24x10022-08-11241002021-08-18
B046220811242000Coated Revision Stem24x20022-08-11242002021-08-18

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