FDA.reportPublic FDA data

3P Hip System

Primary DI
00840536800206
Brand
3P Hip System
Company
ORTHOPEDIATRICS CORP.
Model
01-3002-1025
Catalog number
01-3002-1025
Device description
3P Infant Beam, Transphyseal Trephine
Published
2026-06-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GFGBIT, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFGBit, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840536800206PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840536800206008405368002068405368002060840536800206

GMDN Terms#

Term, Definition table
TermDefinition
Bone trephine, single-useAn orthopaedic surgical blade designed to cut and remove circular sections of bone, typically for biopsy or percutaneous bone graft harvesting. It is typically a hollow cylinder with a circular, saw-like serrated working edge. It is an exchangeable device that may be attached to a manually-operated handle or to a powered rotary surgical handpiece. The device is typically made of high-grade stainless steel. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00840536825087PedFlex Flexible Nailing System00-1001-1140-S00-1001-1140-S2026-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860016074101CARTISTEM® Subchondral Bone Drill Bit - 4mmMedipost, Inc.GFG2026-07-28
008405368002133P Hip SystemORTHOPEDIATRICS CORP.GFG2026-06-12
008405368002203P Hip SystemORTHOPEDIATRICS CORP.GFG2026-06-12
00811714036540ThunderboltRESPONSIVE ORTHOPEDICS LLCGFG2025-05-14
00811714036557ThunderboltRESPONSIVE ORTHOPEDICS LLCGFG2025-05-14
10888277326200MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-02-21
10888277348813MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-02-21
10888277354005MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-02-21
10888277354012MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-02-21
10888277354029MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-02-21
10888277354074MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-02-21
10888277354296MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-02-21
10888277355057MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-02-21
10888277378261MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-02-21
10888277378278MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-02-21
10888277387805MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-02-21
10888277390676MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-02-21
10080196393152MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-01-29
10888277322295MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-01-29
10888277329485MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-01-29
10888277330054MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-01-29
10888277334663MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-01-29
10888277336971MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-01-29
10888277337121MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-01-29
10888277337183MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-01-29
10888277353480MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-01-29
10888277354180MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-01-29
10888277354647MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-01-29
10888277355132MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-01-29
10888277355439MEDLINEMEDLINE INDUSTRIES, INC.GFG2025-01-29