FDA.reportPublic FDA data

REAL INTELLIGENCE

Primary DI
00885556925232
Brand
REAL INTELLIGENCE
Company
Smith & Nephew, Inc.
Model
ROB10013F
Catalog number
ROB10013F
Device description
REFURBISHED REAL INTELLIGENCE ROBOTIC DRILL
Published
2026-07-30
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
OLOOrthopedic stereotaxic instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201022000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201022000REAL INTELLIGENCE CORI (CORI)Blue Belt Technologies, Inc.2020-06-12OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556925232PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556925232008855569252328855569252320885556925232

GMDN Terms#

Term, Definition table
TermDefinition
Bone/joint surgical power tool motorized handpiece/set, electric, reusableAn electrically-powered one-piece device or modular device collection designed to accept an endpiece(s) [e.g., drill bit, saw blade, bur] for drilling, cutting, and/or inserting procedures involving bones and tough tissues during a surgical procedure; it is not dedicated to dental procedures. It includes an electric motor and typically one or more power tool attachments with a Jacobs chuck or quick-connect collet/adaptor at its distal end to connect the endpieces, and may include a rechargeable battery or a control unit; the endpieces are not included. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00-10C-55C
Special Storage Condition, Specify0010-90
Special Storage Condition, Specify0050kPA-106KPA
Special Storage Condition, Specify00Keep dry

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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
00885556925171REAL INTELLIGENCEROB100021FROB100021F2026-07-30
00885556925188REAL INTELLIGENCEROB100022FROB100022F2026-07-30
00885556925195REAL INTELLIGENCEROB10024FROB10024F2026-07-30
00885556925201REAL INTELLIGENCEROB10025FROB10025F2026-07-30
00885556925218REAL INTELLIGENCEROB10027FROB10027F2026-07-30
00885556925225REAL INTELLIGENCEROB10003FROB10003F2026-07-30
00885556925249REAL INTELLIGENCEROB10015FROB10015F2026-07-30
00885556832448Salto Talaris Total Ankle ProsthesisMJU048TMJU048T2023-02-02
00885556165560NA76515310765153102026-07-16
00885556923023NA76547001765470012026-07-16
00885556925089NA74034445740344452026-07-14
00885556925379CORIOGRAPHROB20032ROB200322026-07-08
00885556925386CORIOGRAPHROB20031ROB200312026-07-08
00885556904879EVOS70887105708871052026-06-25
00885556904923EVOS70897130708971302026-06-25
00885556906163EVOS70879090708790902026-06-25
00885556906170EVOS70879095708790952026-06-25
00885556906187EVOS70879100708791002026-06-25
00885556906194EVOS70879105708791052026-06-25
00885556906200EVOS70879110708791102026-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840606195546Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195553Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195560Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195577Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195584Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195591Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195607Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195614Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195621Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195638Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195645Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00840606195652Overwatch PCFSPINAL ELEMENTS, INC.OLO2026-07-30
00885556925171REAL INTELLIGENCESmith & Nephew, Inc.OLO2026-07-30
00885556925188REAL INTELLIGENCESmith & Nephew, Inc.OLO2026-07-30
00885556925195REAL INTELLIGENCESmith & Nephew, Inc.OLO2026-07-30
00885556925201REAL INTELLIGENCESmith & Nephew, Inc.OLO2026-07-30
00885556925218REAL INTELLIGENCESmith & Nephew, Inc.OLO2026-07-30
00885556925225REAL INTELLIGENCESmith & Nephew, Inc.OLO2026-07-30
00885556925249REAL INTELLIGENCESmith & Nephew, Inc.OLO2026-07-30
04054896090955VERTICALESilony Medical GmbHOLO2026-07-30
04054896090962VERTICALESilony Medical GmbHOLO2026-07-30
04054896090979VERTICALESilony Medical GmbHOLO2026-07-30
04054896090986VERTICALESilony Medical GmbHOLO2026-07-30
04054896090993VERTICALESilony Medical GmbHOLO2026-07-30
04054896091006VERTICALESilony Medical GmbHOLO2026-07-30
04054896091013VERTICALESilony Medical GmbHOLO2026-07-30
04054896091020VERTICALESilony Medical GmbHOLO2026-07-30
04054896091037VERTICALESilony Medical GmbHOLO2026-07-30
04054896091044VERTICALESilony Medical GmbHOLO2026-07-30
04054896091051VERTICALESilony Medical GmbHOLO2026-07-30