FDA.reportPublic FDA data

C-CURVE

Primary DI
03613720275657
Brand
C-CURVE
Company
MEDICREA INTERNATIONAL
Model
A20501456
Catalog number
A20501456
Device description
MONOBLOC IMPLANT HOLDER WITH DRILL GUIDE C-CURVE H:5-6 mm
Published
2021-10-07
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
HXKHolder, Needle; Orthopedic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXKHolder, Needle; OrthopedicOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210470000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210470000C-CURVE Interbody Fusion DeviceMedicrea International SA2021-09-03OVE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03613720275657PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03613720275657036137202756573613720275657

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
383228632
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03613720249832PASS TLA220302002017-01-31
03613720286875UNiD OCTB33243600-01B33243600-012021-08-19
03613720286882UNiD OCTB33243500-01B33243500-012021-08-19
03613720286899UNiD OCTB33143600-01B33143600-012021-08-19
03613720286905UNiD OCTB33143500-01B33143500-012021-08-19
03613720286936UNiD RODB33136012-01B33136012-012021-08-19
03613720286943UNiD RODB33236012-01B33236012-012021-08-19
03613720268451UNiD RODB33125512-01B33125512-012017-06-12
03613720268468UNiD RODB33125512-02B33125512-022017-06-12
03613720268628UNiD RODB33225512-01B33225512-012017-06-12
03613720268635UNiD RODB33225512-02B33225512-022017-06-12
03613720268963UNiD RODB33126012-01B33126012-012017-08-28
03613720268970UNiD RODB33126012-02B33126012-022017-08-28
03613720269137UNiD RODB33226012-01B33226012-012017-08-28
03613720269144UNiD RODB33226012-02B33226012-022017-08-28
03613720269304UNiD OCTB33123500-01B33123500-012017-09-12
03613720269311UNiD OCTB33123500-02B33123500-022017-09-12
03613720269397UNiD OCTB33223500-01B33223500-012017-09-12
03613720269403UNiD OCTB33223500-02B33223500-022017-09-12
03613720286585UNiD MISB33155522-01B33155522-012021-02-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776435097MillenniumAvalign Technologies, Inc.HXK2026-10-15
04058749027969NAFehling Instruments GmbH & Co. KGHXK2026-10-12
00190776432782MillenniumAvalign Technologies, Inc.HXK2026-09-29
00724995268916Snowden-PencerSTERIS Deutschland GmbHHXK2026-09-25
00724995268923Snowden-PencerSTERIS Deutschland GmbHHXK2026-09-25
00724995268930Snowden-PencerSTERIS Deutschland GmbHHXK2026-09-25
00724995268947Snowden-PencerSTERIS Deutschland GmbHHXK2026-09-25
00724995268954Snowden-PencerSTERIS Deutschland GmbHHXK2026-09-25
00724995268961Snowden-PencerSTERIS Deutschland GmbHHXK2026-09-25
00724995268978Snowden-PencerSTERIS Deutschland GmbHHXK2026-09-25
04054462904747evonosevonos GmbH & Co. KGHXK2026-08-21
04054462904754evonosevonos GmbH & Co. KGHXK2026-08-21
04054462904761evonosevonos GmbH & Co. KGHXK2026-08-21
04054462904778evonosevonos GmbH & Co. KGHXK2026-08-21
04054462904785evonosevonos GmbH & Co. KGHXK2026-08-21
04054462904792evonosevonos GmbH & Co. KGHXK2026-08-21
00850088713428PRINCETONPrinceton Medical Group, Inc.HXK2026-08-14
00840217910392Ace Medical CompanyEBNER MEDICAL, LLCHXK2026-08-13
00840217910408Ace Medical CompanyEBNER MEDICAL, LLCHXK2026-08-13
00840217910415Ace Medical CompanyEBNER MEDICAL, LLCHXK2026-08-13
00840217910422Ace Medical CompanyEBNER MEDICAL, LLCHXK2026-08-13
00840217910439Ace Medical CompanyEBNER MEDICAL, LLCHXK2026-08-13
00840217910446Ace Medical CompanyEBNER MEDICAL, LLCHXK2026-08-13
00840217910453Ace Medical CompanyEBNER MEDICAL, LLCHXK2026-08-13
00840217910460Ace Medical CompanyEBNER MEDICAL, LLCHXK2026-08-13
00840217910477Ace Medical CompanyEBNER MEDICAL, LLCHXK2026-08-13
00840217910484Ace Medical CompanyEBNER MEDICAL, LLCHXK2026-08-13
04058749047196NAFehling Instruments GmbH & Co. KGHXK2026-07-17
04058749117387NAFehling Instruments GmbH & Co. KGHXK2026-07-17
00850083275235Intrace USAPILOTIS TECH LLCHXK2026-07-03