FDA.reportPublic FDA data

Prone Perfect

Primary DI
00840536822611
Brand
Prone Perfect
Company
ORTHOPEDIATRICS CORP.
Model
03-1300-8808
Catalog number
03-1300-8808
Device description
Prone Perfect Bolt, Long
Published
2026-05-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
JEBTABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, MANUAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEBTable, Surgical With Orthopedic Accessories, ManualGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840536822611PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840536822611008405368226118405368226110840536822611

GMDN Terms#

Term, Definition table
TermDefinition
Operating table patient positioning set, reusableA collection of devices intended to support and stabilize in a desired position a patient, or their body parts, on an operating table during a medical procedure (e.g., bariatric surgery, orthopaedic surgery, endotracheal tube intubation); some types may be intended to prevent a patient from sliding while in the Trendelenburg position or when applying traction. The set consists of multiple items which include two or more of the following: a base plate/bar that serves as a foundation to which patient positioners are attached, clamps/adaptors, and disposable/reusable padded positioners dedicated to a body part (e.g., non-slip positioning pad, headrest). This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
+1(574)268-6379xxx@xxx.com

Regulatory Flags#

DUNS number
796416191
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
008405368002063P Hip System01-3002-102501-3002-10252026-06-12
008405368002133P Hip System01-3002-202501-3002-20252026-06-12
008405368002203P Hip System01-3002-302501-3002-30252026-06-12
00840536822864Response Spine01-1600-001701-1600-00172026-08-21
00840536822871Response Spine01-1300-011201-1300-01122026-08-21
00840536822888Response Spine01-1300-011301-1300-01132026-08-21
00840536822895Response Spine01-1300-611501-1300-61152026-08-21
00840536822901Response Spine01-1300-611601-1300-61162026-08-21
00840536824707Response Spine01-1600-607301-1600-60732026-08-21
00840536824974PedFlex Flexible Nailing System00-1001-1015-S00-1001-1015-S2026-08-14
00840536824981PedFlex Flexible Nailing System00-1001-1020-S00-1001-1020-S2026-08-14
00840536824998PedFlex Flexible Nailing System00-1001-1025-S00-1001-1025-S2026-08-14
00840536825001PedFlex Flexible Nailing System00-1001-1030-S00-1001-1030-S2026-08-14
00840536825018PedFlex Flexible Nailing System00-1001-1035-S00-1001-1035-S2026-08-14
00840536825025PedFlex Flexible Nailing System00-1001-1040-S00-1001-1040-S2026-08-14
00840536825032PedFlex Flexible Nailing System00-1001-1115-S00-1001-1115-S2026-08-14
00840536825049PedFlex Flexible Nailing System00-1001-1120-S00-1001-1120-S2026-08-14
00840536825056PedFlex Flexible Nailing System00-1001-1125-S00-1001-1125-S2026-08-14
00840536825063PedFlex Flexible Nailing System00-1001-1130-S00-1001-1130-S2026-08-14
00840536825070PedFlex Flexible Nailing System00-1001-1135-S00-1001-1135-S2026-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840536822543Prone PerfectORTHOPEDIATRICS CORP.JEB2026-05-22
00840536822550Prone PerfectORTHOPEDIATRICS CORP.JEB2026-05-22
00840536822567Prone PerfectORTHOPEDIATRICS CORP.JEB2026-05-22
00840536822574Prone PerfectORTHOPEDIATRICS CORP.JEB2026-05-22
00840536822581Prone PerfectORTHOPEDIATRICS CORP.JEB2026-05-22
00840536822598Prone PerfectORTHOPEDIATRICS CORP.JEB2026-05-22
00840536822604Prone PerfectORTHOPEDIATRICS CORP.JEB2026-05-22
00840536822628Prone PerfectORTHOPEDIATRICS CORP.JEB2026-05-22
00840536822635Prone PerfectORTHOPEDIATRICS CORP.JEB2026-05-22
00840536822642Prone PerfectORTHOPEDIATRICS CORP.JEB2026-05-22
04251732800383X-Ray Top Seat section PST 500Jörg & Sohn GmbHJEB2026-05-18
04251732800406X-Ray Top Back section PST 500 UJörg & Sohn GmbHJEB2026-05-18
04251732800413Cart for X-Ray TopsJörg & Sohn GmbHJEB2026-05-18
04251732800420Pad leg section light high H GJörg & Sohn GmbHJEB2026-05-18
04251732800437Clamshell Armboard PadJörg & Sohn GmbHJEB2026-05-18
00190776418670MillenniumAvalign Technologies, Inc.JEB2026-04-09
04251732800338X-Ray Top Head sectionJörg & Sohn GmbHJEB2025-06-26
04251732800345X-Ray Top Back section TS7000Jörg & Sohn GmbHJEB2025-06-26
04251732800352X-Ray Top Seat section TS7000Jörg & Sohn GmbHJEB2025-06-26
04251732800369X-Ray Top Universal sectionJörg & Sohn GmbHJEB2025-06-26
04251732800376X-Ray Top Leg section one partJörg & Sohn GmbHJEB2025-06-26
G611BIO110210Alliant BiotechMEDISURGE LLCJEB2024-08-16
G611BIO110220Alliant BiotechMEDISURGE LLCJEB2024-08-16
G611BIO110230Alliant BiotechMEDISURGE LLCJEB2024-08-16
G611BIO110240Alliant BiotechMEDISURGE LLCJEB2024-08-16
G611BIO11024B0Alliant BiotechMEDISURGE LLCJEB2024-08-16
G611BIO11024C0Alliant BiotechMEDISURGE LLCJEB2024-08-16
G611BIO110310Alliant BiotechMEDISURGE LLCJEB2024-08-16
G611BIO110320Alliant BiotechMEDISURGE LLCJEB2024-08-16
G611BIO110330Alliant BiotechMEDISURGE LLCJEB2024-08-16