ClearanceBrief
510(k) K802598 ยท HTT Burr, Orthopedic

CARBIDE CUTTING INSTRUMENT/INTRAARTICU

ApplicantThe Anspach Effort, Inc., Mchenry IL, US
DecisionSubstantially Equivalent, Nov 19, 1980
ReceivedOct 21, 1980
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K802598

DateFirm and productCodeLinked 510(k)
Oct 21, 2011The Anspach Effort, Inc.
"***REF QD11-6B***6 mm Fluted Ball. Use with QD11 Attachments. ***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only***Made in the USA***Manufacturer: The Anspach Effort, Inc. 4500 Riverside D
Terminated
HTTNone listed
Oct 21, 2011The Anspach Effort, Inc.
"***REF QD8-5B***5 mm Fluted Ball. Use with QD8 Attachments. ***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only***Made in the USA***Manufacturer: The Anspach Effort, Inc. 4500 Riverside Dri
Terminated
HTTNone listed
Oct 21, 2011The Anspach Effort, Inc.
"***REF BLU-5***5 mm Fluted Ball. Use with B-BLUE-S Attachment. ***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only***Made in the USA***Manufacturer: The Anspach Effort, Inc. 4500 Riverside
Terminated
HTTNone listed
Oct 21, 2011The Anspach Effort, Inc.
"***REF BLU-39***5 mm Fluted Acorn. Use with B-BLUE-S Attachment. ***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only***Made in the USA***Manufacturer: The Anspach Effort, Inc. 4500 Riversid
Terminated
HTTNone listed
Oct 21, 2011The Anspach Effort, Inc.
"***REF BLU-LS9-5E***4.7 mm x 20 mm Fluted Drum, Side Cut Only. Use with B-BLUE-S Attachment. ***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only ***Made in the USA***Manufacturer: The Anspa
Terminated
HTTNone listed
Oct 21, 2011The Anspach Effort, Inc.
"***REF GRE-1***1.85 mm x 16 mm Fluted Router. Use with B-GREEN Attachments.***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only ***Made in the USA***Manufacturer: The Anspach Effort, Inc. 45
Terminated
HTTNone listed
Oct 21, 2011The Anspach Effort, Inc.
"***REF LHD-6B-M***6 mm Fluted Ball. Use with LONG-HD Attachment. ***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only***Made in the USA***Manufacturer: The Anspach Effort, Inc. 4500 Riversid
Terminated
HTTNone listed
Oct 21, 2011The Anspach Effort, Inc.
'***REF SIL-3-10***1.93 mm Suture Pass Drill/ 1.17 eye. Use with B-SILVER Attachment.***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only ***Made in the USA***Manufacturer: The Anspach Effort
Terminated
HTTNone listed
Oct 21, 2011The Anspach Effort, Inc.
"***REF TURQ-L5***5 mm Fluted Ball. Use with B-TURQ-L Attachment. ***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only***Made in the USA***Manufacturer: The Anspach Effort, Inc. 4500 Rivers
Terminated
HTTNone listed
Oct 21, 2011The Anspach Effort, Inc.
"***REF L-CRN***2.5 mm x 25.4 mm Fluted Router. Use with CRANI-L Attachments.***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only ***Made in the USA***Manufacturer: The Anspach Effort, Inc
Terminated
HTTNone listed
Oct 21, 2011The Anspach Effort, Inc.
"***REF A-CRN***1.85 mm x 16 mm Fluted Router. Use with CRANI-A Attachments.***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only ***Made in the USA***Manufacturer: The Anspach Effort, Inc.
Terminated
HTTNone listed
Oct 21, 2011The Anspach Effort, Inc.
"***REF S-35DC***3.5 mm Coarse Diamond Ball, Extended Length. Use with SHORT Attachments.***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only***Made in the USA***Manufacturer: The Anspach Eff
Terminated
HTTNone listed
Oct 21, 2011The Anspach Effort, Inc.
"***REF S-6AC***6 mm Fluted Acorn. Use with SHORT Attachments. ***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only***Made in the USA***Manufacturer: The Anspach Effort, Inc. 4500 Riverside D
Terminated
HTTNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.