Atlas FDA

CARBIDE CUTTING INSTRUMENT/INTRAARTICU

FDA 510(k) clearance K802598 · decided 1980-11-19

Clearance details

K-number
K802598
Device name
CARBIDE CUTTING INSTRUMENT/INTRAARTICU
Applicant
The Anspach Effort, Inc.
Decision
Substantially Equivalent
Date received
1980-10-21
Decision date
1980-11-19
Days to decision
29 days
Clearance type
Traditional
Product code
HTT
Device class
1
Regulation number
888.4540
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
HALL STERILE BUR (K862529)Hall Surgical, Division of Zimmer, Inc.1986-07-15
MICRO-AIRE REPLAC. DRILL BURS FOR ZIMMER (K821695)Micro-Aire Surgical Instruments, Inc.1982-07-20
BUR, SURGICAL CARBIDE (K760236)Cutter Laboratories, Inc.1976-07-26

Recalls involving this device

RecordFirmDate
"***REF QD11-6B***6 mm Fluted Ball. Use with QD11 Attachments. ***ANSPACH***Sterile, Steri recall (Z-0090-2012)The Anspach Effort, Inc.2011-10-21
"***REF QD8-5B***5 mm Fluted Ball. Use with QD8 Attachments. ***ANSPACH***Sterile, Sterili recall (Z-0091-2012)The Anspach Effort, Inc.2011-10-21
"***REF BLU-5***5 mm Fluted Ball. Use with B-BLUE-S Attachment. ***ANSPACH***Sterile, Ster recall (Z-0092-2012)The Anspach Effort, Inc.2011-10-21
"***REF BLU-39***5 mm Fluted Acorn. Use with B-BLUE-S Attachment. ***ANSPACH***Sterile, St recall (Z-0093-2012)The Anspach Effort, Inc.2011-10-21
"***REF BLU-LS9-5E***4.7 mm x 20 mm Fluted Drum, Side Cut Only. Use with B-BLUE-S Attachme recall (Z-0094-2012)The Anspach Effort, Inc.2011-10-21
"***REF GRE-1***1.85 mm x 16 mm Fluted Router. Use with B-GREEN Attachments.***ANSPACH***S recall (Z-0095-2012)The Anspach Effort, Inc.2011-10-21
"***REF LHD-6B-M***6 mm Fluted Ball. Use with LONG-HD Attachment. ***ANSPACH***Sterile, St recall (Z-0096-2012)The Anspach Effort, Inc.2011-10-21
'***REF SIL-3-10***1.93 mm Suture Pass Drill/ 1.17 eye. Use with B-SILVER Attachment.***AN recall (Z-0097-2012)The Anspach Effort, Inc.2011-10-21
"***REF TURQ-L5***5 mm Fluted Ball. Use with B-TURQ-L Attachment. ***ANSPACH***Sterile, St recall (Z-0098-2012)The Anspach Effort, Inc.2011-10-21
"***REF L-CRN***2.5 mm x 25.4 mm Fluted Router. Use with CRANI-L Attachments.***ANSPACH*** recall (Z-0099-2012)The Anspach Effort, Inc.2011-10-21
"***REF A-CRN***1.85 mm x 16 mm Fluted Router. Use with CRANI-A Attachments.***ANSPACH***S recall (Z-0100-2012)The Anspach Effort, Inc.2011-10-21
"***REF S-35DC***3.5 mm Coarse Diamond Ball, Extended Length. Use with SHORT Attachments.* recall (Z-0101-2012)The Anspach Effort, Inc.2011-10-21
"***REF S-6AC***6 mm Fluted Acorn. Use with SHORT Attachments. ***ANSPACH***Sterile, Steri recall (Z-0102-2012)The Anspach Effort, Inc.2011-10-21