Atlas FDA

HALL STERNUM SAW

FDA 510(k) clearance K862474 · decided 1986-07-17

Clearance details

K-number
K862474
Device name
HALL STERNUM SAW
Applicant
Hall Surgical, Division of Zimmer, Inc.
Decision
Substantially Equivalent
Date received
1986-06-30
Decision date
1986-07-17
Days to decision
17 days
Clearance type
Traditional
Product code
DWH
Device class
1
Regulation number
878.4820
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
`Anta Barbara, CA, 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
CODMAN COLLINS RADIOPARENT STERNAL BLADES (K904352)Codman & Shurtleff, Inc.1990-11-21
MICRO-AIRE STERNUM SAW REPLACEMENT BLADES (K850483)Micro-Aire Surgical Instruments, Inc.1985-03-01
CARDIOVASCULAR SAW BLADES (K830189)Temp Medical Products, Inc.1983-03-24

Recalls involving this device

No recalls on record reference this clearance.