Atlas FDA

BIOMET CONCENTRIC HEX SCREW

FDA 510(k) clearance K781389 · decided 1978-08-21

Clearance details

K-number
K781389
Device name
BIOMET CONCENTRIC HEX SCREW
Applicant
Biomet, Inc.
Decision
Substantially Equivalent
Date received
1978-08-10
Decision date
1978-08-21
Days to decision
11 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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Similar devices under this product code

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

RecordFirmDate
OsteoCentric Integrated Hip Fastener System (K230764)OsteoCentric Technologies2023-04-18
Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screws (K213126)Smith & Nephew, Inc.2022-09-29
OsteoCentric Integrated Hip Fastener System (K210247)Osteocentric Technologies D.B.A. Osteocentric Trauma2021-04-30
CONQUEST FN (K193029)Smith & Nephew, Inc.2020-02-28
THP Hip Fracture Plating System (K173826)Biomet, Inc.2018-02-07
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.

PMA approvals by this applicant

RecordFirmDate
C2A-TAPER ACETABULAR HIP SYSTEM (P050009/S009)Biomet, Inc.2011-02-11
C2A-TAPER ACETABULAR SYSTEM (P050009/S004)Biomet, Inc.2009-04-17
C2A TAPER ACETABULAR SYSTEM (P050009/S007)Biomet, Inc.2009-03-13
C2-A TAPER ACETABULAR SYSTEM (P050009/S005)Biomet, Inc.2007-11-30
C2A-TAPER ACETABULAR SYSTEM (P050009/S002)Biomet, Inc.2006-06-16
C2A-TAPER ACETABULAR SYSTEM (P050009/S001)Biomet, Inc.2006-02-01
C2 A-TAPER ACETABULAR SYSTEM (P050009)Biomet, Inc.2005-12-16