FDA.reportPublic FDA data

RapidSorb

Primary DI
H98085152001S0
Brand
RapidSorb
Company
SYNTHES (U.S.A.) LP
Model
851.520.01S
Catalog number
85152001S
Device description
1.5MM RAPID RESORBABLE MESH 50X50X0.8MM-STERILE
Published
2015-09-14
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
JEYPLATE, BONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEYPlate, BoneDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K030069000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K030069000SYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SYSTEMSynthes (Usa)2003-04-08JEY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10887587063812PrimaryGS10
H98085152001S0SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088758706381210887587063812

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, bioabsorbableA small, implantable sheet of firm material that is attached to fractured long bone fragments with screws to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material is chemically degraded and typically absorbed by natural body processes (e.g., a degradable polymer). The device is typically used for smaller post-traumatic or pathological orthopaedic fractures (e.g., of the hand or wrist). It may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature043 Degrees Celsius
Handling Environment Temperature0110 Degrees Fahrenheit
Special Storage Condition, Specify00.
Storage Environment Temperature5 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature41 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
832637081
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705034718040NA03.620.219036202192018-10-29
10705034767802VentroFix304.8323048322016-12-31
10705034775418NA389.2963892962016-12-31
10705034775425NA389.2973892972016-12-31
10705034775432NA389.2983892982016-12-31
10705034775449NA389.2993892992016-12-31
10705034798455NA690.0386900382016-12-31
10887587039893NA338.7613387612016-12-31
10886982338778MAXFRAME1100022-011100022012024-02-05
10886982338570MAXFRAME1100011-011100011012022-04-26
10886982338587MAXFRAME1100010-011100010012022-04-26
10886982338594MAXFRAME1100012-011100012012022-04-26
10886982338600MAXFRAME1100007-011100007012022-04-26
10886982237217NA510.1615101612019-02-21
10887587039305NA329.37329372016-12-31
10705034741161NA04.616.135046161352015-09-14
10705034741178NA04.616.140046161402015-09-14
10705034741260NA04.616.185046161852015-09-14
10705034741284NA04.616.195046161952015-09-14
10886982027795NA02.007.000S02007000S2015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04046826346812MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-06-25
04046826416676MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-06-25
04046826542337MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-06-25
04046826543655MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-06-25
04046826552473MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-06-25
00888118126528LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2020-04-22
10888118113600LEVEL ONE CMFKLS-Martin L.P.JEY2017-10-20
10888118113617LEVEL ONE CMFKLS-Martin L.P.JEY2017-10-20
00888118001825LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118001870LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118002129LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118002136LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118003041LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118003058LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118003751LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118003775LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118003782LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118003799LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118003805LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118003935LEVEL ONE NEUROKLS-Martin L.P.JEY2016-03-24
00888118003942LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118003959LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118004840LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118005298LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118005304LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118005311LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118005441LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118005458LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118005571LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118005588LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24