WISHBONE

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30131718993013171899WISHBONE1N2026-01-01Rue de l'Expansion Flemalle Liege BE 4400
30136801403013680140WISHBONE MEDICAL INC.1N2026-01-011560 N State Road 5 Larwill IN US 46764

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
05430001477085W-Bone - W-Bone is a xenograft biomaterial composed of hydroxyapatite from bovine origin. It is intended to fill, augment, or reconstruct periodontal defects and/or bony defects of the upper or lower jaw. W-Bone is supplied as a mix of cancellous and cortical particles in a single use thermoformed blister, packaged in a secondary thermoformed blister and sterilized by gamma irradiation.+3242865066info@wishbone-biotech.com
05430001477092W-Bone - W-Bone is a xenograft biomaterial composed of hydroxyapatite from bovine origin. It is intended to fill, augment, or reconstruct periodontal defects and/or bony defects of the upper or lower jaw. W-Bone is supplied as a mix of cancellous and cortical particles in a single use thermoformed blister, packaged in a secondary thermoformed blister and sterilized by gamma irradiation.+3242865066info@wishbone-biotech.com
05430001477108W-Bone - W-Bone is a xenograft biomaterial composed of hydroxyapatite from bovine origin. It is intended to fill, augment, or reconstruct periodontal defects and/or bony defects of the upper or lower jaw. W-Bone is supplied as a mix of cancellous and cortical particles in a single use thermoformed blister, packaged in a secondary thermoformed blister and sterilized by gamma irradiation.+3242865066info@wishbone-biotech.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2087671877315020K230527WishBone Medical Plate and Screw SystemHRS2023-03-29
2087671586479397K213489Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula PlateHRS2022-01-27
3047142009761923K211551Wishbone HANPM2021-08-20
2087671748217230K203467WishBone Medical Plate and Screw SystemHWC2020-12-23
2087671712802029K192674Mixing and Delivery SystemFMF2020-02-18
2087671678974320K182704WishBone Guided Growth SystemOBT2019-06-25
2087671115702257K180736WishBone Medical Plate and Screw SystemHRS2018-10-04
2087671690302560K173013WishBone K-Wire SystemHTY2017-12-14
2087671370933941K161568Bone Solutions Mixing and Delivery SystemFMF2016-09-16
2087671554494425K150661ST.A.R. 90 F4 External Fixation Screws With HydroxyapatiteJDW2015-07-07
2087671807603366K071004OSTEOCRETE BONE VOID FILLERMQV2009-05-21
2087671257405281
2087671390649239
2087671615620267
2087671637870039
2087671759300736
2087671811987199
2087671715387448
2087671746037754
2087671758839253
2087672002967915
2087672063077613

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HRS42023-03-29
FMF22020-02-18
OBT22019-06-25
HTY22017-12-14
NPM12021-08-20
HWC12020-12-23
JDW12015-07-07
MQV12009-05-21

PMN#

GUDID#