FDA.reportPublic FDA data

NA

Primary DI
04546540754769
Brand
NA
Company
STRYKER CORPORATION
Model
234-010-080
Catalog number
234-010-080
Device description
12MM X 25MM BIOABSORBABLE ACL SCREW
Published
2015-09-04
Public version status
Update
Distribution status
Not 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
HWCScrew, fixation, bone

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K033252000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033252000MODIFICATION TO STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEMStryker Endoscopy2003-11-13HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04546540754769PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546540754769045465407547694546540754769

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length25Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature054 Degrees Celsius
Storage Environment Temperature054 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(866)624-4422xx@xx.xx

Regulatory Flags#

DUNS number
187502109
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327682427Excelsior ReachMC17PSJ155-01MC17PSJ155-012026-10-29
07613327682434Excelsior ReachMC17PS90155-01MC17PS90155-012026-10-29
07613327682441Excelsior ReachMC17ST155-01MC17ST155-012026-10-29
07613327682458Excelsior ReachMC17PS45165-01MC17PS45165-012026-10-29
07613327682465Excelsior ReachMC17PS90165-01MC17PS90165-012026-10-29
07613327682496Excelsior ReachMC17PS45155-01MC17PS45155-012026-10-29
07613327682526Excelsior ReachMC17ST165-01MC17ST165-012026-10-29
07613327682571Excelsior ReachMC17PSJ165-01MC17PSJ165-012026-10-29
07613327694796Broadway 8BRW084128-01BRW084128-012026-10-27
07613327141771SpinePlex040622200004062220002016-09-23
07613154355563Discmonitor040729000004072900002016-09-23
07613154358335MixEvac02060200000206-020-0002018-09-24
07613154687152AutoPlex, VertaPlex06056850000605-685-0002016-12-29
07613154687169AutoPlex, VertaPlex06056870000605-687-0002016-12-29
07613252018315PCD, VertaPlex05075890000507-589-0002016-12-29
07613252039259AutoPlex, VertaPlex06076870000607-687-0002017-01-03
07613252648642VertePort X4 Manifold060541150006054115002018-09-24
07613252648659VertePort X4 Manifold060540850006054085002018-09-24
07613252648888VertePort X4 Manifold060541000006054100002018-09-24
07613252648895VertePort X4 Manifold060540800006054080002018-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03700569653873NANEWCLIP TECHNICSHWC2026-11-05
03700569658274NANEWCLIP TECHNICSHWC2026-11-05
03700569658281NANEWCLIP TECHNICSHWC2026-11-05
03700569667931NANEWCLIP TECHNICSHWC2026-11-05
03700569667948NANEWCLIP TECHNICSHWC2026-11-05
03700569667955NANEWCLIP TECHNICSHWC2026-11-05
03700569667962NANEWCLIP TECHNICSHWC2026-11-05
03700569667979NANEWCLIP TECHNICSHWC2026-11-05
03700569667986NANEWCLIP TECHNICSHWC2026-11-05
03700569667993NANEWCLIP TECHNICSHWC2026-11-05
03700569668006NANEWCLIP TECHNICSHWC2026-11-05
03700569668013NANEWCLIP TECHNICSHWC2026-11-05
03700569668020NANEWCLIP TECHNICSHWC2026-11-05
03700569668037NANEWCLIP TECHNICSHWC2026-11-05
03700569668044NANEWCLIP TECHNICSHWC2026-11-05
03700569668051NANEWCLIP TECHNICSHWC2026-11-05
03700569668068NANEWCLIP TECHNICSHWC2026-11-05
03700569668075NANEWCLIP TECHNICSHWC2026-11-05
03700569668082NANEWCLIP TECHNICSHWC2026-11-05
03700569668099NANEWCLIP TECHNICSHWC2026-11-05
03700569668105NANEWCLIP TECHNICSHWC2026-11-05
03700569668112NANEWCLIP TECHNICSHWC2026-11-05
03700569668129NANEWCLIP TECHNICSHWC2026-11-05
03700569668136NANEWCLIP TECHNICSHWC2026-11-05
03700569668143NANEWCLIP TECHNICSHWC2026-11-05
03700569668150NANEWCLIP TECHNICSHWC2026-11-05
03700569668167NANEWCLIP TECHNICSHWC2026-11-05
03700569668174NANEWCLIP TECHNICSHWC2026-11-05
03700569668181NANEWCLIP TECHNICSHWC2026-11-05
03700569668198NANEWCLIP TECHNICSHWC2026-11-05