Atlas FDA

FWZ

61 FDA 510(k) clearances · Product code

26 daysmedian time to decision
77 days90th percentile
61clearances measured

FDA profile

Official device name
Operating Room Accessories Table Tray
Device class
Class I (low risk)
Regulation
21 CFR 878.4950
Medical specialty
General, Plastic Surgery
FDA definition
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Adverse events (MAUDE)
2021: 337 · 2022: 56 · 2023: 28 · 2024: 68 · 2025: 52 · 2026: 37
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
RETRACTOR ARM CLAMP (K960019)Biopsys Medical, Inc.1996-02-09
'LIL MAC ACCESSORY CLAMP(TM) (K945415)D.L. Nelson and Assoc., Inc.1994-11-22
CARBON LIGHTS HAND SURGERY TABLE (K944779)Allen Medical Systems, Inc.1994-10-14
KAPS POSITIONING ARM (K935381)Andronic Devices, Ltd.1994-04-15
WHITMORE VACUUM-LOCK SPINAL FRAME (VLSF-100) (K931037)Whitmore Ent., Inc.1993-07-30
SPONGE COUNTER (K926225)American Medical Manufacturer, Inc.1993-03-05
MIDKIFF GEOSTATIC CLAMP (K925035)D.L. Nelson and Assoc., Inc.1993-02-18
PREP AND OPERATING STAND (K905564)Mcconnell Orthopedic1991-02-21
LATERAL BUTTRESS SUPPORT (K905565)Mcconnell Orthopedic1991-02-21
PARK CITY SHOULDER POSITIONER (K910031)Orthopedic Systems, Inc.1991-01-24
TKO TELESCOPING LITHOTOMY STIRRUP (K904826)D.L. Nelson and Assoc., Inc.1990-10-31
LINCOLN MILLS FOOT AND LEG HOLDER (K897028)Lincoln Mills, Inc.1990-01-12
DECUBITUS CARE PAD (K893969)Gulftrade Exim, Inc.1989-07-14
SECOND ASSISTANT (K890501)3M Company1989-02-10
LINCOLN MILLS HIP HOLDER (K885215)Lincoln Mills, Inc.1989-01-13
FREE ARM(TM) (K884928)Faro Medical Technologies, Inc.1988-12-15
SPINAL SURGERY FRAME (K882078)Karlin Technology, Inc.1988-06-16
WEHBE ARM HOLDER (K880265)Orthopedic Systems, Inc.1988-02-18
VARUS AND VALGUS LEG HOLDER (K873139)Leonard Medical, Inc.1987-09-16
ALLEN MALLEABLE ANESTHESIA SCREEN (K873370)Edgewater Medical Equipment Systems1987-09-11
THE PORTABLE ORDERLY (K872900)Edgewater Medical Equipment Systems1987-08-21
MCCONNELL ORTHOPEDIC TIBIAL POSITIONER (K871823)Mcconnell Orthopedic1987-05-26
MCCONNELL ORTHOPEDIC ANTERIOR TORSO-ARM SUPPORT (K871820)Mcconnell Orthopedic1987-05-26
MCCONNELL ORTHOPEDIC U-HOOK ASSEMBLY (K871822)Mcconnell Orthopedic1987-05-26
MCCONNELL ORTHOPEDIC POSTERIOR BODY SUPPORT (K871821)Mcconnell Orthopedic1987-05-26
MCCONNELL ORTHOPEDIC SUSPENSION SYSTEM (K871824)Mcconnell Orthopedic1987-05-26
MCCONNELL ORTHOPEDIC PELVIC CALIPER SUPPORT (K871839)Mcconnell Orthopedic1987-05-26
MCCONNELL ORTHOPEDIC ANKLE POSITIONER (K871840)Mcconnell Orthopedic1987-05-26
MCCONNELL ORTHOPEDIC SHOULDER/HIP POSITIONER (K871819)Mcconnell Orthopedic1987-05-22
MCCONNELL ORTHOPEDIC STERILE ARTICULATED ARM (K871703)Mcconnell Orthopedic1987-05-19
MCCONNELL ORTHOPEDIC UNIVERSAL POSITIONER (MUP) (K871803)Mcconnell Orthopedic1987-05-19
MCCONNELL ORTHOPEDIC STERILE UPRIGHT SUPPORT (K871805)Mcconnell Orthopedic1987-05-19
MCCONNEL ORTHOPEDIC ARTHROSCOPY SUPPORT ASSEMBLY (K871804)Mcconnell Orthopedic1987-05-19
HAND SURGERY TABLE EXTENSION (K871225)Orthopedic Systems, Inc.1987-04-07
CLARK SOCKET, SIDE RAIL SOCKET, SIDE RAIL SECTION (K870101)Orthopedic Systems, Inc.1987-02-06
LITHOTOMY HOLDERS (K870098)Orthopedic Systems, Inc.1987-02-06
RADIOLUCENT TABLE EXTENSION (K870104)Orthopedic Systems, Inc.1987-02-06
ANKLE HOLDER W/ANKLE SUPPORT KIT FOR LEG HOLDER (K865024)American Container Technology, Inc.1987-01-12
COLLINS POSITIONING DEVICE (K864880)Orthopedic Systems, Inc.1986-12-29
ARTHROSCOPIC ANKLE HOLDER (K864881)Orthopedic Systems, Inc.1986-12-29
RAIL CLAMP EXTENSION PIECE (K864459)American Container Technology, Inc.1986-12-01
C ARM SURGICAL TABLE (K860446)Medi-Mech, Inc.1986-03-10
BASILDON-GARDNER SPINAL FRAME (K842700)Downs Surgical , Ltd.1984-09-12
FPP ARMBOARD STRAP (K840684)Fpp, Inc.1984-04-23
DEVON HEAD REST (K840422)Devon Industries, Inc.1984-03-12
ULNAR NERVE PROTECTOR (K840421)Devon Industries, Inc.1984-03-12
SHUTT UNIVERSAL STRESS POST (K833624)Concept, Inc.1983-11-28
ELEVATOR CUSHION (K832472)Inmed Corp.1983-09-20
PROTET HOLDERS-BLOCKS & ROLL (K830272)Ritmed, Inc.1983-06-03
ACUFEX UNIVERSAL LEG HOLDER (K830707)Acufex Microsurgical, Inc.1983-05-02
CHEMO-TABLE (K830612)Fabrications Unltd.1983-03-29
OMNISURG SIDE MOUNTING CLAMP & RAIL EXT. (K821933)Polamedco, Inc.1982-07-08
ARTHROSCOPY SYSTEM LEG HOLDER (K821029)Zimmer, Inc.1982-04-29
ANTHROSCOPIC SURGICAL TABLE (K820289)The Anspach Effort, Inc.1982-04-21
KNEE SUPPORT FOR X-RAY & SURGERY (K820291)The Anspach Effort, Inc.1982-03-05
O.R. ARMBOARD COVER (K813030)Tecnol New Jersey Wound Care, Inc.1982-01-18
LOWER EXTREMITY SUPPORT SYSTEM-LESS (K810433)Walgen Medical Innoventions1981-03-13
SURCAN KNEE HOLDING DEVICE (K802558)Bend Orthopedic & Fracture Clinic1980-10-31
SURG-ASSIST (K801572)Medmetric Corp.1980-08-04
THE SURGICAL ASSISTANT (K790674)Instrument Makar, Inc.1979-05-14
TABLE, HAND SURGI (K760456)Stryker Corp.1976-11-02

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