FDA.reportPublic FDA data

Orthopaedic ball spike

Definition
A hand-held manual surgical instrument used in the surgical wound to reposition a bone fragment during a surgical intervention. It is typically a robust instrument designed with a handle at the proximal end and a long, sturdy, shaft that terminates in a singularly pointed ball head at the distal end. It is typically made of high-grade stainless steel and/or synthetic material and is used by the surgeon to reposition and hold bone fragments. This is a reusable device.
GUDID devices
91
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00190776413477MillenniumAvalign Technologies, Inc.1-3980032025-10-09
04046955283996SQ.LINEAesculap AGFO103NR2020-05-20
08033390114356SMR ShoulderLIMACORPORATE SPA3 Pegs Glenoid Cement Compactor2016-06-09
08033390114363SMR ShoulderLIMACORPORATE SPA3 Pegs Glenoid Cement Compactor2016-06-09
08033390114370SMR ShoulderLIMACORPORATE SPA3 Pegs Glenoid Cement Compactor2016-06-09
10810190013554Hip Bone Spike — StraightT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIOND2016-09-24
10810190013561Hip Bone Spike — 60˚T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIOND2016-09-24
10810190013578Hip Bone Spike — 40˚T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIOND2016-09-24
10810190015626Microfracture Pick, StraightT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONE2016-09-24
10810190017033Bone Spike, StraightT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONB2016-09-24
10810190017040Hip Bone Pick 40°T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONB2016-09-24
10811998036516OIC Intramedullary Nail SystemORTHOPAEDIC IMPLANT COMPANY, THE01-IM532018-08-07
10886982006707NASynthes GmbHSD397.7302016-12-31
10886982006721NASynthes GmbHSD398.0022016-12-31
10886982006738NASynthes GmbHSD398.0032016-12-31
10886982070678NASynthes GmbH03.100.0182016-12-31
10886982070685NASynthes GmbH03.100.0192016-12-31
10886982076496NASynthes GmbH03.211.4572016-12-31
10886982076557NASynthes GmbH03.211.4632016-12-31
10886982076564NASynthes GmbH03.211.4642016-12-31
10886982201430NASynthes GmbH398.542016-12-31
10886982311122NASynthes GmbH03.164.0112022-11-29
10886982311139NASynthes GmbH03.164.0122022-11-29
10886982362377NASynthes GmbHSD03.211.4582026-05-01
10886982362384NASynthes GmbHSD03.211.4592026-05-01
10886982362391NASynthes GmbHSD03.211.4602026-05-01
10886982362407NASynthes GmbHSD03.211.4612026-05-01
14026704799340PILLINGTELEFLEX INCORPORATEDIPN0560582022-12-08
14026704799357PILLINGTELEFLEX INCORPORATEDIPN0200972022-12-08
M69601IM530OIC Intramedullary Nail SystemORTHOPAEDIC IMPLANT COMPANY, THE01-IM532017-02-03
10810128463185Hip Bone Pick 60°T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION512404t2026-03-19
54026704799355PILLINGTELEFLEX INCORPORATEDIPN0200972022-12-08
00885556911181EVOSSmith & Nephew, Inc.711764142025-11-12
00885556911198EVOSSmith & Nephew, Inc.711764152025-11-12
00885556911372EVOSSmith & Nephew, Inc.711764162025-11-12
00887868582325Affixus®Zimmer, Inc.2113020042024-10-17
09120034300196SpikeI.T.S. GmbH70301-72018-10-24
09120047303528Straight Ball Spike I.T.S. GmbH17-16002018-10-22
09120069812879Plate Holder PinI.T.S. GmbH625112018-11-13
54026704799348PILLINGTELEFLEX INCORPORATEDIPN0560582022-12-08
00190776380632MillenniumAvalign Technologies, Inc.1-479062023-11-03
00850005084426Pacific InstrumentsPACIFIC INSTRUMENTS, INC.PI-36222023-08-22
07612334216649NASynthes GmbH03.164.0112022-11-29
07612334216656NASynthes GmbH03.164.0122022-11-29
09120115620007Ballspike, Straight, L=300mmI.T.S. GmbH640102022-10-19
09120115620014Ballspike, Angled, L=200mmI.T.S. GmbH640112022-10-19
09120115620021Ballspike, Straight, L=200mmI.T.S. GmbH640122022-10-19
00840314247032gSourceGSOURCE LLCgS 87.00202020-03-03
00840314247049gSourceGSOURCE LLCgS 87.00222020-03-03
H679398540NASynthes GmbH398.542016-12-31
H679SD3977300NASynthes GmbHSD397.7302016-12-31
H679SD3980020NASynthes GmbHSD398.0022016-12-31
H679SD3980030NASynthes GmbHSD398.0032016-12-31
07611819796621NASynthes GmbH03.100.0182016-12-31
07611819796638NASynthes GmbH03.100.0192016-12-31
07611819614819NASynthes GmbH03.211.4572016-12-31
07611819614871NASynthes GmbH03.211.4632016-12-31
07611819614888NASynthes GmbH03.211.4642016-12-31
10886982290519NASynthes GmbHSD03.211.4572022-03-04
M930701130000Life InstrumentsLife Instrument Corporation701-1300-02022-02-25
00190776076306AvalignAvalign Technologies, Inc.VM80-19862021-11-03
00190776187255MillenniumAvalign Technologies, Inc.1-80322021-11-01
008890246162198MM BALL SPIKE PUSHER WITH HANDLEZimmer, Inc.SSI0059852021-01-07
04546540370617NAStryker GmbH7029232020-09-24
07613154554898NAStryker GmbH5057-6-3002020-09-24
04046955286157SQ.LINEAesculap AGFO102NR2020-08-10
10886982303318NASynthes GmbHSD03.211.4642020-08-03
10886982303301NASynthes GmbHSD03.211.4632020-07-31
10886982303325NASynthes GmbHSD03.211.4652020-07-31
00887868129742TSP HIP FX PLATING SYSTEMREDUCTION TOOLBiomet Orthopedics, LLC14-4515732016-09-26
00887868164866THP™ Hip Fracture Plating SystemBiomet Orthopedics, LLC14-4515712017-12-29
00887868001871SPIKED DISCBiomet Orthopedics, LLC135812017-04-07
00887868001918BALL SPIKEBiomet Orthopedics, LLC135882017-04-07
M7558700200gSourceGSOURCE LLCgS 87.00202020-03-03
M7558700220gSourceGSOURCE LLCgS 87.00222020-03-03
M7558720060gSource GSOURCE LLCgS 87.20062020-03-03
00889024575202Alliance®Zimmer, Inc.SBGL37012020-02-28
08033390095228SMR ShoulderLIMACORPORATE SPACompactor2016-04-09
08033390095235SMR ShoulderLIMACORPORATE SPACompactor2016-04-09
08033390095242SMR ShoulderLIMACORPORATE SPACompactor2016-04-09