Atlas FDA

CORSTREN COMPRESSION TUBE & PLATE

FDA 510(k) clearance K830196 · decided 1983-03-25

Clearance details

K-number
K830196
Device name
CORSTREN COMPRESSION TUBE & PLATE
Applicant
Zimmer, Inc.
Decision
Substantially Equivalent
Date received
1983-01-20
Decision date
1983-03-25
Days to decision
64 days
Clearance type
Traditional
Product code
KTT
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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Devices cleared under the same product code - the starting set for predicate research.

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Monkey Rings External Ring Fixation System (K253613)Paragon 28, Inc.2025-12-19
Medusa Orthopedics Boa External Fixation System (K252555)Medusa Orthopedics, LLC2025-11-25
The Response Ortho Smart Fixator - Hexapod System (K252625)Response Ortho Solutions, LLC2025-11-20
External Fixation Mini Rail System (K252106)Paragon 28, Inc.2025-09-30
External Fixation Bone Distractor (K251862)Paragon 28, Inc.2025-08-11
SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) (K250472)Amdt Holdings, Inc.2025-08-08
Extremity Medical External Fixation System (K251128)Extremity Medical, LLC2025-05-07

Recalls involving this device

RecordFirmDate
Product 30 consists of all product under product code: KTT and same usage: Item no: 118100 recall (Z-1128-2016)Zimmer Manufacturing B.V.2016-03-12
Trauma Tubes and Plates: TUBE & SCP PLT 90DX150LG TUBE & SCP PLT 90DX205LG TUBE & SCP PLT recall (Z-2550-2014)Zimmer, Inc.2014-08-26
FREE-LOCK LAG SCREW, 12.7, FREE-LOCK LAG SCREW, 15.8, FREE-LOCK SUPRACOND TUBE and FREE-LO recall (Z-1003-2014)Zimmer, Inc.2014-02-20
Free Lock Femoral Hip Fixation System Compression Lag Screw . Several lengths (55 to 150 m recall (Z-2090-2013)Zimmer, Inc.2013-08-26
Free Lock Femoral Hip Fixation System Compression Tube/Plate, different length (59, 75, 91 recall (Z-2091-2013)Zimmer, Inc.2013-08-26
VERSA-FX FEMORAL FIXATION SYSTEM COMPRESSION LAG SCREW, several length (55 mm to 155 mm), recall (Z-2092-2013)Zimmer, Inc.2013-08-26
VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and short low profile recall (Z-2093-2013)Zimmer, Inc.2013-08-26
VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and short - low profi recall (Z-2094-2013)Zimmer, Inc.2013-08-26

PMA approvals by this applicant

RecordFirmDate
NexGen© LPSFlex/ LPS Mobile Bearing Knee System (P060037/S095)Zimmer, Inc.2025-08-18
NexGen© LPSFlex/LPS Mobile Bearing Knee System (P060037/S093)Zimmer, Inc.2025-04-09
NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S094)Zimmer, Inc.2025-04-01
NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S092)Zimmer, Inc.2024-12-12
NexGen® LPS-Flex LPS-Mobile Bearing Knee (P060037/S091)Zimmer, Inc.2024-07-05
NexGen® LPS-Flex / LPS Mobile Bearing Knee System (P060037/S090)Zimmer, Inc.2024-05-17
NexGen LPS-Flex/LPS Mobile Bearing Knee System (P060037/S089)Zimmer, Inc.2024-04-04
NexGen® LPS-Flex/LPS Mobile Bearing Knee System (P060037/S088)Zimmer, Inc.2024-02-13