FDA.reportPublic FDA data

INTEGRITY IMPLANTS INC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30127976303012797630INTEGRITY IMPLANTS INC1N2020-04-25354 Hiatt Drive Palm Bch Gdns FL US 33418

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
00810004722491NA - French Bender800.201.9300customerservice@integrityimplants.com
00810004722507NA - In-Situ Benders 5.0 mm Rod - Left800.201.9300customerservice@integrityimplants.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1965021043715894K190360LineSider™ Spinal SystemNKB2019-06-21
1965021870914250K183184FlareHawk Interbody Fusion SystemMAX2019-04-03
1965021273133586K182114FlareHawk Interbody Fusion SystemMAX2019-01-07
1965021229706940K160076XCage™ Interbody Fusion SystemMAX2016-10-13
1965021692177720K133514XCAGE INTERBODY FUSION SYSTEMMAX2014-05-01
1965021007628511
1965021193768037
1965021241176361
1965021498583540
1965021526856106
1965021701345192
1965021921458565
1965021955623837
1965021961172166
1965022036357227

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MAX42019-04-03
NKB12019-06-21

PMN#

GUDID#

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