FDA.reportPublic FDA data

B-P INTERNAL FIXATION ACCESSORIES

Primary DI
00814193025647
Brand
B-P INTERNAL FIXATION ACCESSORIES
Company
ENDOTEC, INC.
Model
03-04-0011
Catalog number
03-04-0011
Device description
B-P MODULAR EXTENSION SCREW W/O ULTRACOAT
Published
2015-09-17
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
KWLProsthesis, Hip, Hemi-, Femoral, Metal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWLProsthesis, Hip, Hemi-, Femoral, MetalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K884789000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K884789000NEW JERSEY FEMORAL HIP PROSTHESIS FOR CEMENT APPLIProtek, Inc.1989-02-08KWL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814193025647PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814193025647008141930256478141930256470814193025647

GMDN Terms#

Term, Definition table
TermDefinition
Total shoulder prosthesisA sterile implantable artificial substitute for a shoulder joint designed to replace both articulating surfaces of the damaged (e.g., fractured) and/or degenerative (e.g., arthritic) joint. It includes glenoid and humeral (head and stem) components typically with parts made of metal and polyethylene (PE). Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
803488357
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814193020017B-P TOTAL KNEE SYSTEM04-31-200104-31-20012015-09-17
00814193020031B-P TOTAL KNEE SYSTEM04-31-200204-31-20022015-09-17
00814193020062B-P TOTAL KNEE SYSTEM04-31-100404-31-10042015-09-17
00814193020116B-P TOTAL KNEE SYSTEM04-31-200604-31-20062015-09-17
00814193020253B-P TOTAL KNEE SYSTEM04-31-220104-31-22012015-09-17
00814193020505B-P TOTAL KNEE SYSTEM04-31-150204-31-15022015-09-17
00814193020529B-P TOTAL KNEE SYSTEM04-31-150304-31-15032015-09-17
00814193020536B-P TOTAL KNEE SYSTEM04-31-250304-31-25032015-09-17
00814193020543B-P TOTAL KNEE SYSTEM04-31-150404-31-15042015-09-17
00814193020574B-P TOTAL KNEE SYSTEM04-31-250504-31-25052015-09-17
00814193020581B-P TOTAL KNEE SYSTEM04-31-150604-31-15062015-09-17
00814193020628B-P TOTAL KNEE SYSTEM04-32-000304-32-00032015-09-17
00814193020666B-P TOTAL KNEE SYSTEM04-32-001104-32-00112015-09-17
00814193020673B-P TOTAL KNEE SYSTEM04-32-001204-32-00122015-09-17
00814193020710B-P TOTAL KNEE SYSTEM04-32-001604-32-00162015-09-17
00814193020734B-P TOTAL KNEE SYSTEM04-32-002204-32-00222015-09-17
00814193020789B-P TOTAL KNEE SYSTEM04-32-006104-32-00612015-09-17
00814193020802B-P TOTAL KNEE SYSTEM04-32-006304-32-00632015-09-17
00814193020826B-P TOTAL KNEE SYSTEM04-32-006504-32-00652015-09-17
00814193020833B-P TOTAL KNEE SYSTEM04-32-006604-32-00662015-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09348215199890Triple Taper Stem Standard Offset Collared Size 0SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09348215199906Triple Taper Stem High Offset Collared Size 0SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09348215199913Triple Taper Stem Standard Offset Collarless Size 0SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09348215199920Triple Taper Stem High Offset Collarless Size 0SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09348215199937Triple Taper Stem Standard Offset Collared Size 1SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09348215199944Triple Taper Stem High Offset Collared Size 1SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09348215199951Triple Taper Stem Standard Offset Collarless Size 1SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09348215199968Triple Taper Stem High Offset Collarless Size 1SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09348215199975Triple Taper Stem Standard Offset Collared Size 2SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09348215199982Triple Taper Stem High Offset Collared Size 2SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09348215199999Triple Taper Stem Standard Offset Collarless Size 2SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09363272000002Triple Taper Stem High Offset Collarless Size 2SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09363272000019Triple Taper Stem Standard Offset Collared Size 3SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09363272000026Triple Taper Stem High Offset Collared Size 3SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09363272000033Triple Taper Stem Standard Offset Collarless Size 3SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09363272000040Triple Taper Stem High Offset Collarless Size 3SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09363272000057Triple Taper Stem Standard Offset Collared Size 4SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09363272000064Triple Taper Stem High Offset Collared Size 4SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09363272000071Triple Taper Stem Standard Offset Collarless Size 4SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09363272000088Triple Taper Stem High Offset Collarless Size 4SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09363272000095Triple Taper Stem Standard Offset Collared Size 5SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09363272000101Triple Taper Stem High Offset Collared Size 5SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09363272000118Triple Taper Stem Standard Offset Collarless Size 5SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09363272000125Triple Taper Stem High Offset Collarless Size 5SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09363272000132Triple Taper Stem Standard Offset Collared Size 6SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09363272000149Triple Taper Stem High Offset Collared Size 6SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09363272000156Triple Taper Stem Standard Offset Collarless Size 6SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09363272000163Triple Taper Stem High Offset Collarless Size 6SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09363272000170Triple Taper Stem Standard Offset Collared Size 7SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22
09363272000187Triple Taper Stem High Offset Collared Size 7SIGNATURE ORTHOPAEDICS PTY LTDKWL2026-09-22