FDA.reportPublic FDA data

KEYSTONE MANUFACTURING

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30082368463008236846KEYSTONE MANUFACTURING1N2026-01-016387 Technology Ave Ste B Kalamazoo MI US 49009

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1121361444300368K181702Tranquil-L Interbody SystemMAX2018-09-21
1121361192609008K181621Stable-C Interbody SystemOVE2018-10-19
1121361502765174K181483Tranquil Interbody SystemMAX2018-08-27
1121361611835508K172617Treace Medical Concepts (TMC) Compression Screw SystemHWC2017-10-25
1121361361026068K170297Tranquil Interbody SystemMAX2017-06-27
1121362014144973K162046MINNE TIES MMF Suture SystemDYX2017-04-11
1121361007207045K160820PressON Pro Spinal Fixation SystemNKB2016-06-28
1121361695321820K153531Treace Medical Concepts (TMC) Plating SystemHRS2016-01-07
1121361331908263K151261Invia Foam Dressing Kit Small, Invia Foam Dressing Kit Medium, Invia Foam Dressing Kit LargeOMP2015-10-07
1121361689023193K143717Treace Medical Concepts(TMC) Plating SystemHRS2015-03-19
1121361944563850K133287PRESSON SPINAL FIXATION SYSTEMMNH2014-02-25
1121362045513842K001337DANIELS SHARPSMART REUSABLE SHARPS CONTAINERMMK2000-07-05
1121361965781061
1121361065584291
1121361128246371
1121361162973986
1121361213068593
1121361260076664
1121361363474504
1121361429775730
1121361463904819
1121361471328292
1121361560522707
1121361577789237
1121361674052012
1121361719655969
1121361728583170
1121361746402499
1121361832050467
1121361909171309
1121361951731393
1121361962039618
1121362010772522
1121362033284420

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MAX32018-09-21
HRS22016-01-07
OVE12018-10-19
HWC12017-10-25
DYX12017-04-11
NKB12016-06-28
OMP12015-10-07
MNH12014-02-25
MMK12000-07-05

GUDID#