Atlas FDA

SABA-COOMBS MINI EXTERNAL FIXATOR

FDA 510(k) clearance K842343 · decided 1984-09-11

Clearance details

K-number
K842343
Device name
SABA-COOMBS MINI EXTERNAL FIXATOR
Applicant
Zimmer, Inc.
Decision
Substantially Equivalent
Date received
1984-06-14
Decision date
1984-09-11
Days to decision
89 days
Clearance type
Traditional
Product code
JEC
Device class
2
Regulation number
888.3040
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
SteriTrak (K203605)Arbutus Medical, Inc.2021-04-23
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DigiFix Sterile Kit (K192465)Virak Orthopedics, LLC2019-10-10
PIP Fix (K181192)Hand Biomechanics Lab, Inc.2018-10-22
Anjon Bremer Halo System (K171863)Anjon Holdings, LLC2018-03-19
Medline ReNewal Reprocessed Stryker External Fixation Devices (K163028)Surgical Instrument Service and Savings, Inc.2016-12-28
DIGIFIX EXTERNAL FIXATION SYSTEM (K132731)Virak Orthopedic Research, LLC2014-01-10
HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, HOFFMANN II EX (K102885)Stryker Corp.2011-01-14
LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X (K082679)Sintea Biotech, Inc.2009-04-07
F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE (K072432)Hand Biomechanics Lab, Inc.2008-01-09
SYNTHES (USA) 2ND GENERATION PELVIC C-CLAMP (K071476)Synthes (Usa)2007-08-24
KLSA MARTIN HAND DISTRACTOR (K042066)KLS-Martin L.P.2004-08-25

Recalls involving this device

No recalls on record reference this clearance.

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