FDA.reportPublic FDA data

NA

Primary DI
10885862027573
Brand
NA
Company
Exactech, Inc.
Model
145-02-08
Catalog number
145-02-08
Device description
INSERTER HEAD, CONSTRAINING SNAP RING, SIZE H
Published
2022-08-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KWZProsthesis, hip, constrained, cemented or uncemented, metal/polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K040601000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040601000EXACTECH ACUMATCH A-SERIES & MCS CONSTRAINED ACETABULAR LINERSExactech, Inc.2004-10-04KWZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885862027573PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088586202757310885862027573

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.

Device Sizes#

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

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
157565946
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885862094780OpteCure650-00-01650-00-012016-07-17
10885862094797OpteCure650-00-02650-00-022016-07-17
10885862094803OpteCure650-00-05650-00-052016-06-17
10885862094810OpteCure650-00-10650-00-102016-07-17
10885862094827Optecure650-00-20650-00-202016-09-19
10885862094841OpteCure+CCC652-00-01652-00-012016-07-17
10885862094858OpteCure+CCC652-00-02652-00-022016-07-17
10885862094865OpteCure+CCC652-00-05652-00-052016-07-17
10885862094872OpteCure+CCC652-00-10652-00-102016-07-17
10885862094889OpteCure+CCC652-00-20652-00-202016-07-17
10885862095039Ossigen660-00-20660-00-202016-07-17
10885862252593Entice +CCC692-00-01692-00-012016-07-17
10885862252609Entice +CCC692-00-02692-00-022016-07-17
10885862252616Entice +CCC692-00-05692-00-052016-07-17
10885862252623Entice +CCC692-00-10692-00-102016-07-17
10885862252630Entice +CCC692-00-20692-00-202016-07-17
10885862252845Entice690-00-01690-00-012016-07-17
10885862252852Entice690-00-02690-00-022016-07-17
10885862252869Entice690-00-05690-00-052016-07-17
10885862252876Entice690-00-10690-00-102016-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
E31442100200SignatureMaterialise NVKWZ2026-09-24
E31442100300SignatureMaterialise NVKWZ2026-09-24
09348215199890Triple Taper Stem Standard Offset Collared Size 0SIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-09-22
09348215199906Triple Taper Stem High Offset Collared Size 0SIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-09-22
09348215199913Triple Taper Stem Standard Offset Collarless Size 0SIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-09-22
09348215199920Triple Taper Stem High Offset Collarless Size 0SIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-09-22
09348215199937Triple Taper Stem Standard Offset Collared Size 1SIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-09-22
09348215199944Triple Taper Stem High Offset Collared Size 1SIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-09-22
09348215199951Triple Taper Stem Standard Offset Collarless Size 1SIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-09-22
09348215199968Triple Taper Stem High Offset Collarless Size 1SIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-09-22
09348215199975Triple Taper Stem Standard Offset Collared Size 2SIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-09-22
09348215199982Triple Taper Stem High Offset Collared Size 2SIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-09-22
09348215199999Triple Taper Stem Standard Offset Collarless Size 2SIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-09-22
09363272000002Triple Taper Stem High Offset Collarless Size 2SIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-09-22
09363272000019Triple Taper Stem Standard Offset Collared Size 3SIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-09-22
09363272000026Triple Taper Stem High Offset Collared Size 3SIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-09-22
09363272000033Triple Taper Stem Standard Offset Collarless Size 3SIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-09-22
09363272000040Triple Taper Stem High Offset Collarless Size 3SIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-09-22
09363272000057Triple Taper Stem Standard Offset Collared Size 4SIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-09-22
09363272000064Triple Taper Stem High Offset Collared Size 4SIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-09-22
09363272000071Triple Taper Stem Standard Offset Collarless Size 4SIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-09-22
09363272000088Triple Taper Stem High Offset Collarless Size 4SIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-09-22
09363272000095Triple Taper Stem Standard Offset Collared Size 5SIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-09-22
09363272000101Triple Taper Stem High Offset Collared Size 5SIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-09-22
09363272000118Triple Taper Stem Standard Offset Collarless Size 5SIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-09-22
09363272000125Triple Taper Stem High Offset Collarless Size 5SIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-09-22
09363272000132Triple Taper Stem Standard Offset Collared Size 6SIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-09-22
09363272000149Triple Taper Stem High Offset Collared Size 6SIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-09-22
09363272000156Triple Taper Stem Standard Offset Collarless Size 6SIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-09-22
09363272000163Triple Taper Stem High Offset Collarless Size 6SIGNATURE ORTHOPAEDICS PTY LTDKWZ2026-09-22