Atlas FDA

COMPRESSION SYSTEM

FDA 510(k) clearance K831076 · decided 1983-04-28

Clearance details

K-number
K831076
Device name
COMPRESSION SYSTEM
Applicant
Kirschner Medical Corp.
Decision
Substantially Equivalent
Date received
1983-04-04
Decision date
1983-04-28
Days to decision
24 days
Clearance type
Traditional
Product code
JDO
Device class
2
Regulation number
888.3030
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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CONQUEST FN (K172785)Smith & Nephew2017-12-22
CONQUEST FN (K152686)Smith & Nephew2016-03-17
TSP HIP FRACTURE PLATING SYSTEM (K140018)Biomet, Inc.2014-04-04
HIPLOC COMPRESSION HIP SCREW (K080685)Biomet Manufacturing, Inc.2008-08-15
INTERTAN CHS LOCKING PLATE SYSTEM PROX FEM PLATES/SCREW (K080434)Smith & Nephew, Inc.2008-04-10
GOTFRIED PERCUTANEOUS COMPRESSION PLATING SYSTEM (K983814)Efratgo, Ltd. HI Tech Bio-Surgical1999-01-14
SYNTHES (USA) DHS HELIX SYSTEM (K981757)Synthes (Usa)1998-07-17

Recalls involving this device

No recalls on record reference this clearance.