ClearanceBrief
Panels › General, Plastic Surgery › Product code OJH · Class 1

Orthopedic Tray

Regulation 878.4800

0510(k)s in 12 months (0 all time)
35recalls in 12 months (239 all time)
3recalls that name a 510(k)
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Top companies in OJH

DateFirm and productCodeLinked 510(k)
Oct 15, 2026Medline Industries, LP
Medline surgical convenience kits labeled as: 1) SPINAL CDS, Medline Product Number/SKU CDS940087AM; 2) CUSTOM CRANI, Medline Product Number/SKU DYNJ907697C; 3) FEM POP PACK-LF, Medline Product Nu
Open, Classified
OJHNone listed
Sep 24, 2026Medline Industries, LP
Medline Convenience Kits: 1) ANTERIOR SPINE PACK, Catalog Number: DYNJT10197; 2) CRANIOTOMY #IMF 56646-LF, Catalog Number: DYNJVB91001; 3) CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348O; 4) SLUH
Open, Classified
OJHNone listed
Sep 3, 2026Cardinal Health 200, LLC
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, CHONY ORTHO MAJOR SPINE , Catalog Number: POV2SCCPP; 2) KIT,ORTHOPLASTIC MICROVASCULAR, Catalog Number:
Open, Classified
OJHNone listed
Aug 31, 2026Medline Industries, LP
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ORTHO ASPIRATION KIT DYKM1636A
Open, Classified
OJHNone listed
Aug 31, 2026Medline Industries, LP
Medline Convenience Kits: 1) ORTHO ASPIRATION KIT, Model Number: DYKM1636A; 2) SHOULD BLOCK KIT, Model Number: DYKM1881A; 3) TRIMA KIT, Model Number: DYNDB3077C
Open, Classified
OJHNone listed
Aug 28, 2026AVID Medical, Inc.
Halyard medical convenience kits labeled as: 1) A-P PACK - 205936, Model/Item Number (kit) ANAP22-01; 2) POSTERIOR PACK - 205960, Model/Item Number (kit) ANPP15-01; 3) ANEURYSM PACK, Model/Item Nu
Open, Classified
OJHNone listed
Aug 26, 2026Medline Industries, LP
Medline convenience kits labeled as: 1) LAMI FUSION, Medline Kit SKU CDS982035Y; 2) NON MB MJR NEURO CRANI SM PK, Medline Kit SKU DYNJT6104; 3) CRANIOTOMY, Medline Kit SKU DYNJ903471I; 4) KIT CRA
Open, Classified
OJHNone listed
Aug 21, 2026Medline Industries, LP
Medline medical convenience kits, labeled as: 1) LAMINECTOMY PACK, Medline Kit SKU DYNJT6548; 2) ORTHO SPINE PACK, Medline Kit SKU DYNJ44504G; 3) NEURO SPINE PACK, Medline Kit SKU DYNJ45419F; 4)
Open, Classified
OJHNone listed
Aug 20, 2026American Contract Systems Inc
American Contract Systems medical procedure kits and trays labeled as: 1) ANTERIOR CERVICAL PACK - 205988, Model Item Number MHAC65AH; 2) SPINE PACK - 206013, Model Item Number MHSP99AF.
Open, Classified
OJHNone listed
Aug 13, 2026Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1) KIT, MER NEURO BACK , Catalog Number: PN33NBMYD; 2) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCH4; 3) KIT,CHP BASIC NEURO , Catalog
Open, Classified
OJHNone listed
Jul 24, 2026Windstone Medical Packaging, Inc.
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Laminectomy Pack, Pack Number AMS13574A; 2) ACDF/Fusion Pack, Pack Number AMS14710B; 3) Spine Pack, Pack Number AMS14991A; 4)
Open, Classified
OJHNone listed
Jul 23, 2026Medline Industries, LP
Medline medical convenience kits labeled as: 1) TOTAL JOINT PACK Medline Kit SKU DYNJ65065A: 2) EXTREMITY/FOOT PACK Medline Kit SKU DYNJ65066B: 3) ANTERIOR CERVICAL-SMH Medline Kit SKU DYNJ907718B
Open, Classified
OJHNone listed
Jul 23, 2026Medline Industries, LP
MEDLINE medical procedure convenience kit labeled as: 1) TOTAL KNEE-LF, Medline kit SKU CDSOPT590T; 2) TOTAL KNEE-LF, Medline kit SKU CDSOPT590U; 3) TOTAL KNEE CDS, Medline kit SKU CDS983930J; 4)
Open, Classified
OJHNone listed
Jul 22, 2026Medline Industries, LP
MEDLINE convenience kits labeled as: 1) TOTAL JOINT KIT, Medline Kit SKU DYKS1574A; 2) TOTAL KNEE BASIC, Medline Kit SKU DYNJ902378J; 3) TOTAL HIP, Medline Kit SKU DYNJ903492K; 4) ANTERIOR HIP, M
Open, Classified
OJHK213481
Jul 15, 2026Medline Industries, LP
Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK-LF DYNJ61651J
Open, Classified
OJHNone listed
Jun 25, 2026Medline Industries, LP
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CRANIOTOMY PACK-LF DYNJ0101292F DYNJ0101292G HYBRID PACK DYNJ65925A LAMINECTOMY DYNJ905156L DYNJ905156M DY
Open, Classified
OJHNone listed
Jun 17, 2026Medline Industries, LP
MEDLINE Medical Procedure Kits labeled as: 1) CRANI, Medline Kit Number/SKU DYNJ908097; 2) CRANI, Medline Kit Number/SKU DYNJ908097A; 3) CRANI, Medline Kit Number/SKU DYNJ908097B; 4) CRANI, Medli
Open, Classified
OJHNone listed
Jun 12, 2026Medline Industries, LP
Medline convenience kits: ACD DYNJ904999J ACDF DYNJ907336B DYNJ910821A ACDF PACK DYNJ81098C ACL DYNJ911996 ACL ACCESSORY PACK DYNJ86584B ACL- LF DYNJ905281B ACL PACK DYNJ67271A ALIF DYNJ904848
Open, Classified
OJHNone listed
Jun 11, 2026AVID Medical, Inc.
Halyard, Eye Bag Pack. Kit Code: UIEB48-01.
Open, Classified
OJHNone listed
Jun 11, 2026AVID Medical, Inc.
Halyard, Drape Pack. Kit Code: LMDP36-01.
Open, Classified
OJHNone listed
Jun 11, 2026AVID Medical, Inc.
Halyard, Pain Pack. Kit Code: AMPK48-01.
Open, Classified
OJHNone listed
May 28, 2026Medline Industries, LP
Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPINAL ANESTHESIA TRAY-LF, Medline Kit SKU DYNJRA0102A; 2) SPINAL TRAY-LF, Medline Kit SKU DYNJRA0143B;
Open, Classified
OJHNone listed
May 28, 2026Medline Industries, LP
Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: SPINAL BLOCK 22G QUINCKE 5S BU, Medline Kit SKU DYNJRA9026
Open, Classified
OJHNone listed
May 7, 2026Medline Industries, LP
See RES for complete list. Medline Convenience Kits: 1) SPINAL CDS, Model Number: CDS940087AG; 2) SPINAL CDS, Model Number: CDS940087AI; 3) TOTAL HIP CDS-LF, Model Number: CDS980832Q; 4) TOTAL HIP CDS
Open, Classified
OJHNone listed
May 1, 2026AVID Medical, Inc.
Halyard CATH LAB kit. Model Number: SACL75-01.
Open, Classified
OJHNone listed
Apr 30, 2026Medline Industries, LP
Medline medical procedure kits, containing Medline Neuro Sponges (4077 in total), LAMINECTOMY, CRANI, etc.
Open, Classified
OJHNone listed
Apr 17, 2026Medline Industries, LP
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes EXTREMITY PACK DYNJ34846C HAND PACK DYNJ83218A, DYNJ85396 LAMINECTOMY DYNJ905156R MAJOR EXTREMITY DYNJ9051
Open, Classified
OJHNone listed
Apr 17, 2026Medline Industries, LP
Medline Kits: 1) BWNBORO CRANIOTOMY PACK-LF, Model Number: DYNJ32841F; 2) CRANIOTOMY PACK-LF, Model Number: DYNJ46069D 3) CAMPUS EXTREMITY PK, Model Number: DYNJ51935A 4) FOOT -XRAY BOWL MEDCUP SPECC
Open, Classified
OJHNone listed
Apr 7, 2026Medline Industries, LP
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. SHOULDER ARTHROSCOPY PACK, Medline SKU # DYNJ30880M
Open, Classified
OJHNone listed
Apr 1, 2026Medline Industries, LP
MEDLINE ANTERIOR HIP PACK DYNJ64672B
Open, Classified
OJHNone listed
Feb 17, 2026Medline Industries, LP
Medline Convenience Kits: 1) SPINAL CDS, Model Number: CDS940087AG; 2) SPINAL CDS, Model Number: CDS940087AI; 3) TOTAL HIP CDS-LF, Model Number: CDS980832Q; 4) TOTAL HIP CDS-LF, Model Number: CDS98
Open, Classified
OJHNone listed
Jan 28, 2026Medline Industries, LP
Medline medical procedure convenience kits labeled as: 1) WATKINS SPINE PACK-LF, Kit SKU DYNJ0275635M; 2) SM-SPINE PACK-LF, Kit SKU DYNJ0395037X; 3) TOTAL HIP PACK, Kit SKU DYNJ04809N; 4) MAIN/LA
Open, Classified
OJHNone listed
Jan 12, 2026Medline Industries, LP
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) RR-PLASTIC CRANIOFACIAL PK-LF, Medline kit SKU DYNJ0395085V; 2) NH PERI DISC PACK, Medline kit SK
Open, Classified
OJHNone listed
Nov 14, 2025Medline Industries, LP
MEDLINE convenience kits labeled as: 1) NEURO CRANIOTOMY CDS #36-RF, REF CDS780119V; 2) BASIC BACK CDS, REF CDS780147N; 3) INSTRUMENTED BACK CDS, REF CDS780148R; 4) NEURO-LAMI CDS, REF CDS780208I
Open, Classified
OJHNone listed
Nov 13, 2025Medline Industries, LP
Convenience kits; DYNJ901047R ORTHO SPINE FUMICH DYNJ902308K TOTAL JOINT DYNJ909111F DR SALMA'S SPINE DYNJ909117G PATTERSON TOTAL JOINT DYNJ909113F KYPHOPLASTY
Open, Classified
OJHNone listed
Oct 16, 2025American Contract Systems Inc.
Medical convenience kits Item Number/Description ANSH14AF SHOULDER PACK - 205962 EVAH76H ANTERIOR HIP PACK FDSA15M SHOULDER ARTHROSCOPY GRTS90G TOTAL SHPULDER PACK HGHI26G HIP PINNING PACK HJTO25C
Open, Classified
OJHNone listed
Sep 26, 2025Medline Industries, LP
Sterile Medline Convenience Kits: 1) EXTREMITY PACK, Model Number: DYNJ45701B
Open, Classified
OJHNone listed
Aug 28, 2025American Contract Systems Inc
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ANTERIOR HIP PACK, MODEL/ITEM NUMBER AMAH40N; 2)TOTAL KNEE DAN MYER, MODEL/ITEM NUMBER CCKM67F; 3)HIP PROTHESIS PACK, MOD
Open, Classified
OJHNone listed
Jun 6, 2025American Contract Systems, Inc.
LOWER EXTREMITY, Model: NCEX20I; LOWER EXTREMITY, Model: NCEX20J; TOTAL KNEE PACK, Model: NCTK31K; TOTAL KNEE PACK, Model: NCTK31L All convenience kits contain Specialist Blend Cast Padding, Item: Q
Open, Classified
OJHNone listed
May 31, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ACCESSORY PACK SKU DYNJ59270 2. CRANI PACK-LF SKU DYNJ44805M 3. CRANIOTOMY SKU CDS982719V CDS982719W DYNJ904168F DYNJ908404B D
Open, Classified
OJHNone listed
May 1, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline procedure kits, labeled as: HAND, REF DYNJ902002J
Open, Classified
OJHNone listed
Apr 17, 2025MEDLINE INDUSTRIES, LP - Northfield
Refer to RES
Open, Classified
OJHNone listed
Mar 26, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline procedure kits labeled as: 1) ACL ARTHROSCOPY PACK, Pack Number DYNJ55316G; 2) ARTERIOGRAM PACK, Pack Number DYNJ64332; 3) ARTHRO PACK-LF, Pack Number DYNJ38748F; 4) ARTHRO PACK-LF, Pack
Open, Classified
OJHNone listed
Mar 14, 2025MEDLINE INDUSTRIES, LP - Northfield
Proxima Drape labeled as ORTHO TRAUMA CDS, TOTAL KNEE AUX PACK, TOTAL HIP PACK, TOTAL HIP, TOTAL KNEE, SPINE. Sterile surgical drape.
Open, Classified
OJHNone listed
Mar 14, 2025American Contract Systems Inc
TOTAL HIP PACK , Model No SMTH06O SMTH06P
Open, Classified
OJHNone listed
Mar 14, 2025American Contract Systems Inc
HIP SCOPE, Model Nos. CCHS21B CCHS21B-01 CCHS21B-02
Open, Classified
OJHNone listed
Feb 10, 2025Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP11; 2) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP12 3) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP13 4) CHI S
Open, Classified
OJHNone listed
Jan 15, 2025Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PGVMFFBLY; 2) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PGVMFFBLZ; 3) KIT,NEURO SPINE,ANDERSON , Catalog N
Open, Classified
OJHNone listed
Dec 30, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline custom medical procedure kits labeled as: 1) CRANI, REF CDS780089V; 2) CRANIOFACIAL CDS, REF CDS780102K; 3) CRANIOFACIAL CDS, REF CDS780102L; 4) CRANIOFACIAL CDS, REF CDS780102M; 5) CRAN
Open, Classified
OJHNone listed
Dec 20, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline brand, medical procedure convenience kits, labeled as: 1) LAMINECTOMY CDS-LF, SKU CDS780045N; 2) NEURO CRANIOTOMY CDS #36-RF, SKU CDS780119U; 3) NEURO CRANIOTOMY CDS #36-RF, SKU CDS780119V;
Open, Classified
OJHNone listed

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