FDA.reportPublic FDA data

CURVTEK CARTRIDGE

Primary DI
00880304408166
Brand
CURVTEK CARTRIDGE
Company
Biomet Orthopedics, LLC
Model
906758
Catalog number
906758
Published
2016-09-22
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSZINSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSZInstrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/AttachmentGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K972860000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K972860000CURVTEK TSR SYSTEMBiolectron, Inc.1997-10-31HSZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304408166PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304408166008803044081668803044081660880304408166

GMDN Terms#

Term, Definition table
TermDefinition
Arthroscopic shaver system handpiece, line-poweredA handle with attached cutting blade that is a component of a line-powered arthroscopic shaver system designed for soft and bone tissue resection during arthroscopic surgery on a joint, e.g., a knee, shoulder, or ankle. It is typically connected to and regulated by a dedicated control unit. It may facilitate additional functions of the system (e.g., irrigation/suction) and is used in combination with appropriate endoscopic devices. This is a reusable device.

Device Sizes#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-9500customerservice@zimmerbiomet.com

Regulatory Flags#

DUNS number
129278169
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887868561368VersaNail®2810-13-0372810130372023-09-07
00889024707061A.L.P.S.®2142-35-0072142350072026-05-11
00889024707078DRILL BIT2312002012312002012026-05-11
00889024707085DRILL BIT8290-29-0708290290702026-05-11
00880304410541FIBER OPTICS FOR RC RETRACTOR9085349085342019-06-11
00880304321946BIFURCATED FIBER OPTIC CABLE31-55550231-5555022017-07-28
008803044639124MM X 9FT. LIGHT CABLE9061179061172017-07-28
00889024707054CALIBRATED DRILL BIT2142-27-0702142270702026-04-27
00880304233102Biomet® Knee System1418721418722015-10-24
00880304233126Biomet® Knee System1418741418742015-10-24
00880304233140Biomet® Knee System1418761418762015-10-24
00880304233164Biomet® Knee System1418781418782015-10-24
00880304233171Biomet® Knee System1418801418802015-10-24
00880304233188Biomet® Knee System1418821418822015-10-24
00880304433403Vanguard® Knee System1841441841442015-10-24
00880304433410Vanguard® Knee System1841811841812015-10-24
00880304433564Vanguard® Knee System1842851842852015-10-24
00880304433984Vanguard® Knee System1842801842802015-10-24
00880304434356Vanguard® Knee System1842651842652015-10-24
00880304434363Vanguard® Knee System1842701842702015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150001989MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHSZ2026-03-09
10845854028636POWERPROConmed CorporationHSZ2023-09-01
10845854036198POWERPROConmed CorporationHSZ2023-09-01
10845854036204POWERPROConmed CorporationHSZ2023-09-01
30845854083950CONMEDConmed CorporationHSZ2022-06-06
10845854028384POWERPROConmed CorporationHSZ2021-04-19
10886982186041NASynthes GmbHHSZ2019-12-27
10886982186126NASynthes GmbHHSZ2019-12-27
10886982186317NASynthes GmbHHSZ2019-12-27
10886982186355NASynthes GmbHHSZ2019-12-27
10886982186430NASynthes GmbHHSZ2019-12-27
10886982186454NASynthes GmbHHSZ2019-12-27
10886982186478NASynthes GmbHHSZ2019-12-27
10886982186492NASynthes GmbHHSZ2019-12-27
10886982186515NASynthes GmbHHSZ2019-12-27
10886982186553NASynthes GmbHHSZ2019-12-27
10886982186645NASynthes GmbHHSZ2019-12-27
10886982186706NASynthes GmbHHSZ2019-12-27
10886982186775NASynthes GmbHHSZ2019-12-27
10886982186850NASynthes GmbHHSZ2019-12-27
10886982186874NASynthes GmbHHSZ2019-12-27
10886982185914NASynthes GmbHHSZ2019-12-26
10886982185976NASynthes GmbHHSZ2019-12-26
10886982186034NASynthes GmbHHSZ2019-12-26
10886982186119NASynthes GmbHHSZ2019-12-26
10886982186201NASynthes GmbHHSZ2019-12-26
10886982186218NASynthes GmbHHSZ2019-12-26
10886982186249NASynthes GmbHHSZ2019-12-26
10886982186270NASynthes GmbHHSZ2019-12-26
10886982186294NASynthes GmbHHSZ2019-12-26